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A Bockisch

Publications and source records attributed to A Bockisch.

At least 37 records · Page 2Linked to original sources
PubMed2002

Diagnosis of a cardiac angiosarcoma by fluorine-18 fluordeoxyglucose positron emission tomography.

Cardiac angiosarcoma is a rare tumour entity with a poor prognosis. Early detection is difficult but important for the further course of the disease. We report on a young patient with a tumour of unknown origin and dignity of the right atrium. Magnetic resonance imaging, CT and echocardiography were sufficient in localisation, but no statement on the dignity was possible. Furthermore, staging led to ambiguous results. Malignancy could be proved by fluorine-18 fluordeoxyglucose positron emission tomography, leading to early surgery. Histology revealed a poorly differentiated angiosarcoma.

Adolescent↗
PubMed2002

Influence of therapy with iodine-131 on thyroid tissue pattern in colour and power Doppler sonography.

AIM: The aim of this study was to evaluate the influence of radioiodine therapy on sonographic thyroid patterns using power Doppler (PD) and colour Doppler (CD) sonography in hyperthyroid patients with autonomous nodules (AN) and Graves' disease (GD). METHOD: B-mode, colour, and power Doppler sonography, (99m)Tc scintigraphy, and laboratory analyses (free thyronine fT(3), free thyroxine fT(4), thyroid stimulating hormone TSH) were performed in 55 patients (AN = 27, GD = 28) before and 6 months following therapy with (131)I radioiodine therapy (RIT). RESULTS: In patients with an AN (but not in GD), a significant reduction in thyroid vascularization was subjectively noted following radioiodine therapy on both CD and PD ultrasound (Wilcoxon matched pairs, P < 0.05). The pre-therapeutic grade of hypervascularization in the periphery of autonomous nodules correlated closely with the laboratory parameters of hyperthyroidism. As expected, PD indicated a higher grade of vascularization when compared with CD due to its greater sensitivity to flow. CONCLUSIONS: Radioiodine therapy led to a significant reduction in hypervascularization in patients with AN (but not in GD) corresponding to the normalization of serological values. Comparing CD and PD, PD detected a greater number of vessels. CD and PD are not able to replace scintigraphy and/or laboratory analyses in the management of patients with hyperthyroidism.

Adult↗
PubMed2002

Surveillance of TSH-suppressive levothyroxine treatment in thyroid cancer patients: TRH testing versus basal TSH determination by a third generation assay.

OBJECTIVE, DESIGN AND METHODS: Although TRH testing has been eliminated in the diagnosis of most benign thyroid diseases, it is still controversial whether or not it can be replaced by ultrasensitive determination of basal TSH for monitoring optimal TSH suppression in thyroid cancer patients. We compared basal and TRH-stimulated TSH values measured by a 2 nd generation assay (lower detection limit 0.1 mU/l) and by a 3 rd generation assay (lower detection limit 0.005 mU/l) in 209 thyroidectomized thyroid cancer patients under suppressive levothyroxine treatment. RESULTS: In the 2 nd generation assay all patients had basal TSH values < 0.1 mU/l (criterion of admission in the study), and the TRH-stimulated TSH values were above the lower detection limit in 47% of the patients (range < 0.1-1.0 mU/l). In the 3 rd generation assay TSH was above the lower detection limit in 67% under basal conditions (range < 0.005-0.098 mU/l), and in 83% after TRH stimulation (range < 0.005-1.000 mU/l). We observed close correlations (p < 0.001) between basal and TRH-stimulated TSH in the 3 rd generation assay (r = 0.86), between TRH-stimulated TSH in the 2 nd and 3 rd generation assay (r = 0.95), and between TRH-stimulated TSH in the 2 nd generation assay and basal TSH in the 3 rd generation assay (r = 0.73). The ratio between TRH-stimulated and basal TSH values was in the average range 7-9 : 1. Subdividing the patients in three subgroups based on the TRH-stimulated TSH values from the 2 nd generation assay, the corresponding basal TSH values (median and [25.-75. percentile]) from the 3 rd generation assay were < 0.005 [< 0.005-0.010] mU/l in subgroup A (2 nd generation stim. TSH: < 0.15 mU/l), 0.032 [0.021-0.040] mU/l in subgroup B (2 nd generation stim. TSH: 0.15-0.4 mU/l), and 0.066 [0.046-0.085] mU/l in subgroup C (2 nd generation stim. TSH: > or = 0.5 mU/l). CONCLUSIONS: Even in those thyroid cancer patients where a high degree of TSH suppression is the therapeutic goal, 3 rd generation TSH assays enable a reliable adjustment of the levothyroxine dose by basal TSH determinations. In laboratories still using 2 nd generation assays, the monitoring of maximal TSH suppression in patients with high-risk thyroid cancer should be performed by TRH testing.

Adolescent↗
PubMed2001

[Clinical value of positron emission tomography (PET) in the diagnosis of bone and soft tissue tumors. 3rd Interdisciplinary Consensus Conference "PET in Oncology": results of the Bone and Soft Tissue Study Group].

PURPOSE: In the framework of the 3rd Consensus Conference "PET in Oncology" the bone and soft-tissue tumors study group evaluated the present position of PET for these tumor entities on the basis of international publications. METHODS: After a systematic review of the literature, publications were evaluated according to previously defined quality criteria. For various indications the clinical usefulness of PET was assessed using a classification system. RESULTS: Most studies had been performed with a small number of patients (n < 35). Therefore, only 8 of 46 publications were judged relevant. On the basis of these literature data, use of FDG-PET for grading was classified 1b (literature results predominantly show clinical usefulness). As before (1995/97), all other indications were categorized with 3 (assessment not yet possible, literature data inadequate). OUTLOOK: According to the opinion of experts, the detection of osseous metastases of Ewing's sarcoma, therapy monitoring and the diagnosis of recurrences are potentially useful clinical indications for FDG-PET. Therefore, prospective studies with large patient groups are essential to further evaluate the benefit of FDG-PET in these indications.

Age Factors↗
PubMed2001

Parametric oesophageal multiple swallow scintigraphy for validation of dysphageal symptoms during external beam irradiation of mediastinal tumours.

The aim of the study was to evaluate dysphageal symptoms and to measure the effect of local analgesic treatment using parametric oesophageal multiple swallow scintigraphy (PES) during external beam irradiation of the mediastinal region. Fifteen patients (most with lung cancer) with dysphagia grade II underwent PES during external beam radiotherapy of the mediastinum before and after application of local analgesics. Dynamic parametric condensed images were recorded. The intensity of clinical symptoms was correlated with the emptying rate at 10 s (ER-10 s) and the mean transit time (MTT). Visual analysis of the images was performed and the results were correlated with the fields of irradiation portals. Of the 15 patients, 12 showed a correlation between irradiation portals and the region of oesophageal motility disorder. Concordant results of clinical symptoms and PES data were found. In nine patients with a decrease in dysphagia following local analgesia, an increase in mean ER-10 s and a decrease in MTT were observed. In three patients with deterioration in clinical symptoms after analgesic treatment, a similar decrease in mean ER-10 s was found, though MTT remained constant. In three patients with normal values, motility disorders were detected in the dynamic study. In conclusion, PES was found to be a sensitive tool for the validation of dysphageal symptoms in patients during external beam irradiation of mediastinal tumours and for the evaluation and quantification of the efficacy of local analgesic treatment. Additional visual analysis of the dynamic study is helpful in diagnosing minimal disorders.

Adult↗
PubMed2001

Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo-controlled, double-blind study.

OBJECTIVE: To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation. DESIGN: Prospective, randomized, placebo-controlled, double-blind trial. SETTING: University hospital, Germany. PATIENTS: 48 patients who had radiotherapy to the head and neck. MAIN OUTCOME MEASURES: Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score). RESULTS: 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P=0.07). The RTOG score showed significantly fewer acute side-effects of radiation in the experimental arm (P<0.05). CONCLUSION: The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis.

Adult↗
PubMed2001

Radionuclide-labeled somatostatin analogues for diagnostic and therapeutic purposes in nonmedullary thyroid cancer.

Despite the fact that several recent studies report an expression of somatostatin receptors in nonmedullary thyroid cancer (non-MTC), there is still no consensus concerning the diagnostic and therapeutic usefulness of radionuclide-labeled somatostatin analogues in non-MTC. We present the results of 50 scintigraphic studies with (111)In-Pentetreotide ((111)In-P) in 48 patients with metastasizing non-MTC (n = 9 papillary, n = 9 follicular, n = 29 Hurthle cell, n = 1 insular carcinoma). The findings were compared with histology and with other imaging modalities. (111)In-P provided unequivocally positive results in 37 of 50 (74%) of the patients (27% in the 11 patients with current thyroglobulin levels <10 ng/mL and 85% in the patients with thyroglobulin >10 ng/mL). Histopathology demonstrated that maximal uptake was observed in Hurthle cell carcinoma (95% positive examinations if thyroglobulin exceeds 10 ng/mL). We also describe for the first time dosimetric and clinical data from the courses of 90Y-DOTATOC therapy in three patients with progressive, somatostatin-receptor-positive non-MTC (up to 9.3 GBq per 4 cycles). Tumor progression could not be stopped in any of the patients treated with 90Y-DOTATOC. We conclude that (111)In-P is a promising tool for whole-body diagnosis in nonradioiodine-accumulating non-MTC, especially in Hürthle cell cancer, and if 2-[18F]fluorodeoxyglucose-positron emission tomography (FDG-PET) is not available. Although the number of patients treated with 90Y-DOTATOC is still limited, our applied treatment protocol appears to be ineffective in metastasizing non-MTC.

Adult↗
PubMed2001

SPECT imaging with [123I]-beta-CIT in Parkinsonism: comparison of SPECT images obtained by a single-headed and a three-headed gamma camera.

Single photon emission computed tomography (SPECT) imaging of dopamine transporters by using the cocaine derivative [123I]-(1R)-2-beta-carbomethoxy-3-beta-(4-iodophenyl)-tropane ([123I]-beta-CIT) has been shown to be useful in patients with Parkinsonism. The aim of this study was to compare beta-CIT imaging with single-headed (SHS) and three-headed gamma camera systems (THS). In 17 patients with Parkinsonism, SPECT imaging with an SHS and a THS was performed 24 h after injection of 180 MBq of [123I]-beta-CIT. The SPECT studies were evaluated by visual assessment of the caudate nucleus (CN) and the putamen (PT) and the calculation of the striatal/cerebellar (S/C) ratios (with additional comparison to clinical symptoms measured by the Unified Parkinson's Disease Rating Scale (UPDRS)). The S/C ratios measured by the SHS and THS showed highly significant correlation (two-tailed P < 0.01) with Spearman correlation coefficients (SCCs) of 0.864 for the right side, 0.676 for the left side, and 0.761 for both sides. By the SHS, a sufficient visual differentiation between the CN and the PT could not be achieved. A significantly better distinction could be achieved by using the THS (Wilcoxon P<0.05). The S/C ratios of the THS only showed a significant (P < 0.05) SCC of -0.514 comparing to the UPDRS. Pathological alterations in the beta-CIT uptake pattern could be identified by using the SHS, but a significantly better differentiation of CN and the PT was possible by using the THS. The significant correlation of the S/C ratios measured by THS only emphasizes the value of THS in beta-CIT imaging.

Aged↗
PubMed2001

A double-blind trial of perindopril and nitrendipine in incipient diabetic nephropathy.

UNLABELLED: We conducted a randomised, double-blind multicentre trial to compare the efficacy of the inhibitor of the angiotensin-converting enzyme (ACE) perindopril (P) with nitrendipine (N) in incipient diabetic nephropathy. METHODS: Forty-six patients with insulin-treated diabetes mellitus and mild-to-moderate hypertension and stable microalbuminuria were examined. P 4 or 8 mg once daily was compared to N 20 or 40 mg once daily; an optional open combination treatment with indapamide 2.5 mg once daily was given when needed. Main outcome measures were urinary albumin excretion rate, creatinine clearance and isotopic clearance measurements after 12 months. RESULTS: Baseline characteristics (blood pressure, HbA1, renal function) were highly comparable between groups. No serious adverse events occurred during the study period. Blood pressure was controlled (<140/90 mmHg) in all patients except for one in each group who dropped out. At the end of the study, albumin excretion rate was stabilized in both groups (P: 72% of baseline, N: 108%, NS). There were no significant differences found in radiometric clearance measurements. Creatinine clearance rose in patients treated with P by 10.0 ml/min on average, while it decreased by 9.8 m/min under N treatment (group effect: p<0.05). CONCLUSIONS: In this head-to-head comparison, P and N were effective in stabilising most parameters of renal function in incipient diabetic nephropathy.

Adolescent↗
PubMed2000

The value of fluorine-18 fluorodeoxyglucose PET in patients with medullary thyroid cancer.

The early detection of metastases from medullary thyroid cancer (MTC) is important because the only curative therapy consists in surgical removal of all tumour tissue. There is no single sensitive diagnostic imaging modality for the localization of all metastases in patients with MTC. Therefore, in many cases several imaging modalities (e.g. ultrasonography, magnetic resonance imaging, computerized tomography and scintigraphy using pentavalent technetium-99m dimercaptosuccinic acid, thallium-201 chloride, indium-111 pentetreotide, anti-CEA antibodies or metaiodobenzylguanidine) must be performed consecutively in patients with elevated calcitonin levels until the tumour is localized. In this prospective study, we investigated the value of fluorine-18 fluorodeoxyglucose positron emission tomography ([18F]FDG PET) in the follow-up of patients with MTC. [18F]FDG PET examinations of the neck and the chest were performed in 20 patients with elevated calcitonin levels or sonographic abnormalities in the neck. Positive [18F]FDG findings were validated by histology, computerized tomography or selective venous catheterization. [18F]FDG PET detected tumour in 13/17 patients (nine cases were validated by histology, four by computerized tomography). Five patients showed completely negative PET scans (of these cases, one was true-negative and four false-negative). One patient with [18F]FDG accumulation in pulmonary lesions from silicosis and one patient with a neck lesion that was not subjected to histological validation had to be excluded. Considering all validated localizations, [18F]FDG PET detected 12/14 tumour manifestations in the neck, 6/7 mediastinal metastases, 2/2 pulmonary metastases and 2/2 bone metastases. In two patients with elevated calcitonin levels, no diagnostic modality was able to localize a tumour. The sensitivity of [18F]FDG PET in the follow-up of MTC was 76% (95% confidence interval 53%-94%); this is encouraging. [18F]FDG PET promises to be a valuable diagnostic method, especially for the detection of lymph node metastases, surgical resection of which can result in complete remission.

Adult↗
PubMed2000

Improved diagnostic methods in the follow-up of medullary thyroid carcinoma by highly specific calcitonin measurements.

Calcitonin (CT) is an important tumor marker for medullary thyroid carcinoma (MTC). Recent CT assays chiefly recognize the monomeric form of CT (mCT). It was the objective of this study to examine the consequences of the higher specificity of the assay for interpretation of the postoperative CT values in MTC patients. The postoperative mCT concentration was measured in 214 patients with differentiated thyroid carcinoma (MTC excepted; non-MTC patients) to determine a reference range of mCT in totally thyroidectomized patients. Monomeric CT was also determined with a two-site chemiluminescence immunoassay (Nichols) in 94 healthy subjects and in 68 MTC patients. The mCT concentrations were below the detection limit in all examined completely thyroidectomized non-MTC patients. Basal and stimulated mCT values were also below the detection limit in 32 of the 68 MTC patients. The biochemical and imaging diagnosis of the latter patients did not give any indication of tumor recurrence. We conclude that completely thyroidectomized patients with non-MTC do not show any measurable mCT concentrations. In comparison with an unspecific CT-RIA, the more specific mCT determination by immunoluminometric assay permits a more precise differentiation between postoperative normal and pathological values and an earlier diagnosis of recurrent MTC.

Adult↗
PubMed2000

Induction of DNA single-strand breaks by 131I and 99mTc in human mononuclear blood cells in vitro and extrapolation to the in vivo situation.

The radionuclides (131)I and (99m)Tc are frequently used for therapy of benign and malignant thyroid disease ((131)I) and for diagnosis of thyroid and other diseases ((99m)Tc). However, the levels of DNA single-strand breaks (SSBs) induced in cells of patients after administration of (131)I and (99m)Tc are not known. In this study, we measured the number of SSBs per cell induced by (131)I and (99m)Tc in vitro, extrapolated the results to the clinical situation, and assessed their biological relevance by comparing levels of SSBs induced after therapeutic administration of (131)I and (99m)Tc to those induced by endogenous processes or by occupational exposure to genotoxic substances. A linear dose-response relationship between the radioactivity concentrations of (131)I and (99m)Tc and SSBs in human mononuclear blood cells (determined by alkaline elution) was obtained after incubation at 4 and 37 degrees C. At 4 degrees C, where almost no repair of SSBs takes place, (131)I and (99m)Tc induced 81 and 7 SSBs per cell per hour/(MBq/ml), respectively. At 37 degrees C, only 20 and 1.6 SSBs per cell per hour/(MBq/ml) were observed after incubation with (131)I and (99m)Tc. To estimate the induction of SSBs in vivo in cells of patients after administration of 3700 MBq (131)I (oral) or 60 MBq (99m)Tc (i.v.), the rates of induction of SSBs obtained in vitro were extrapolated to the concentrations of (131)I and (99m)Tc measured in blood of patients. The total number of SSBs (mean +/- standard deviation) accumulated after oral administration of 3700 MBq (131)I up to 70 h after administration was calculated as 200 +/- 59 SSBs/cell. After administration of 60 MBq (99m)Tc (i.v.), 0.032 +/- 0.009 SSBs per cell (total SSBs up to 2 h after administration) were cumulated. The induction of SSBs by endogenous processes (estimated 2,000 SSBs per cell per hour) and by occupational exposure to genotoxic substances (125-430 SSBs per cell) has been estimated in earlier studies. In conclusion, the frequency of SSBs induced by thyroid diagnosis with 60 MBq (99m)Tc is approximately 5 orders of magnitude smaller than the frequency of spontaneous SSBs and thus is most probably without biological relevance. Since the frequency of induction of SSBs by therapy with (131)I (3700 MBq) is about 6000-fold higher compared to thyroid diagnosis by (99m)Tc, its biological relevance is more difficult to assess. Nevertheless, the number of SSBs induced by therapy with (131)I is substantially lower than that induced by endogenous processes.

DNA Damage↗
PubMed2000

[Relationship between thyroglobulin and reliability of thallium 201 scintigraphy in differentiated thyroid cancer].

AIM: Tumor scintigraphy with 201-TlCl is an established diagnostic method in the follow-up of differentiated thyroid cancer. We investigated the relationship between thyroglobulin (Tg) level and tumor detectability. SUBJECT AND METHODS: We analyzed the scans of 122 patients (66 patients with proven tumor). The patient population was divided into groups with Tg above (N = 33) and below (N = 33) 5 ng/ml under TSH suppression or above (N = 33) and below (N = 33) 50 ng/ml under TSH stimulation. Tumor detectability was compared by ROC-analysis (True-Positive-Fraction test, specificity 90%). RESULTS: There was no significant difference (sensitivity 75% versus 64%; p = 0.55) for patients above and below 5 ng/ml under TSH suppression and a just significant difference (sensitivity 80% versus 58%; p = 0.04) for patients above and below 50 ng/ml under TSH stimulation. In 18 patients from our sample with tumor, Tg under TSH suppression was negative, but 201-TlCl-scan was able to detect tumor in 12 patients. CONCLUSION: Our results demonstrate only a moderate dependence of tumor detectability on Tg level, probably without significant clinical relevance. Even in patients with slight Tg elevation 201-TlCl scintigraphy is justified.

Adenocarcinoma, Follicular↗
PubMed2000

Correlation of radionuclide ventriculography with roentgenological findings in chemotherapy patients.

Radionuclide ventriculography (RNV) is a common method to evaluate cardiotoxic effects of drugs applied during chemotherapeutic treatment, whereas thoracic radiographs are used to detect morphologic alterations. Aim of this study was to identify radiographic signs, which correlate with RNV parameters and with RNV image quality. For this study, RNV data of 116 patients receiving chemotherapy acquired during 205 RNV studies (some patients underwent up to 7 follow-up examinations) were correlated to roentgenologic findings assessed by 176 thoracic radiographs. Isolated thoracic radiographic signs of cardiac failure showed only slight correlations to left ventricular ejection fractions measured with radionuclide ventriculography, but the orientation of correlation (positive or negative) could be confirmed well by clinical data. This fact matches clinical experience, that radiographic signs of heart insufficiency can surely predict heart damage only when several of them coincide. By the help of this study it was possible to detect radiographic findings, which are of relevance in patients with suspicion of cardiotoxic damage as side effect of high-dose chemotherapy. The clinical value of several radiologic findings should be reassessed to diagnose cardiac failure in chemotherapy patients.

Adolescent↗
PubMed1999

Non-invasive characterization of cardiac microvascular disease by nuclear medicine using single-photon emission tomography.

In about 10 to 30% of patients with typical angina undergoing coronary angiography for suspicion of stenotic coronary artery disease angiographically normal coronary arteries are found. Kemp et al. in 1973 coined the term syndrome X to describe this entity. In a substantial portion of these patients pathologic findings in myocardial scintigraphy are present. Sensitivity and specificity of thallium-201 exercise imaging by visual analysis of images in the presence of significant coronary stenosis is 84 and 88%, respectively. Several investigators have reported abnormal results in radionuclide exercise tests in patients with angiographically normal coronary arteries. Some of these results can be explained by myocardial bridging, vasospasm, left or right bundle branch block, hypertrophic cardiomyopathy, or absorption artifacts. In the majority of cases, however, these abnormalities are not sufficient to explain the scintigraphic findings. Formerly often claimed "false positive", recent studies suggest that endothelial dysfunction might be the reason for the observed perfusion defects. When comparing patients with angiographically unobstructed coronary arteries with and without perfusion defects in stress myocardial perfusion imaging, patients with pathological results show a significantly lower increase of coronary flow after intracoronary injection of the endothelial-dependent vasodilator acetylcholine. Endothelial-independent vasodilation, however, is not impaired in these patients. In addition, intracoronary Doppler measurements reveal that perfusion defects in myocardial scintigraphy only occur if coronary blood flow in this perfusion area is significantly reduced. These results suggest that regional endothelial dysfunction may cause hypoperfusion in myocardial perfusion imaging and underline the important role of the microcirculation in the distribution of radiotracers. Another striking scintigraphic pattern in patients with microvascular angina is the high incidence of reverse redistribution. These perfusion defects, apparent in images obtained 4 hours after exercise stress testing, often cannot be assigned to the perfusion territory of one of the major epicardial vessels. This results in a marked inhomogeneous radionuclide distribution pattern in resting images. The inhomogeneity is associated with a significant reduced resting coronary flow velocity in these patients. As histologically confirmed microvessel disease is often accompanied by slow-flow phenomenon reflecting decreased resting flow velocity, the results suggest that the inhomogeneous perfusion pattern is caused by microvascular dysfunction. Furthermore, the heterogeneity of nuclide distribution supports the hypothesis that endothelial function is not homogeneous in the entire myocardial microcirculation, but varies considerably. In conclusion, microvascular dysfunction by itself seems to cause regional myocardial hypoperfusion, as documented by myocardial scintigraphy. When interpreting pathological scintigraphic results in patients without significant epicardial stenosis, true blood flow and myocardial perfusion abnormalities must be assumed.

Animals↗
PubMed1999

[Prospective double-blind study of prophylaxis of radioxerostomia with Coumarin/Troxerutine in patients with head and neck cancer].

AIM: Prospective, randomized placebo-controlled double-blind study to prove the efficacy of Coumarin/Troxerutine (Venalot Depot) for protection of salivary glands during a head and neck irradiation. PATIENTS AND METHOD: Forty-eight radiotherapy patients (60 Gy) with head and neck cancer were included in this trial. During radiotherapy the salivary glands were located in the core irradiation field. Primary efficacy parameters were sialometry, quantitative salivary gland scintigraphy and clinical evaluation of early effects of radiotherapy (RTOG-score, Table 1). All data were collected at 6 assessments: 1 week pre-radiation (U1), at start (U2), half time (U3) and end (U4) of irradiation, 8 days (U5) and 28 days (U6) after the end of irradiation (Figure 1). RESULTS: Twenty-three patients (11 verum, 12 placebo) completed the study with all assessments. Sialometrically, all patients were severely (half of radiotherapy) or completely (end of radiotherapy) xerostomatic (Figure 2). In a global efficacy measure according to O'Brien combining scintigraphy and RTOG there was a tendency for a higher efficacy of verum compared to placebo (p = 0.068). After start of irradiation therapy, the RTOG-score showed continuously and significantly lower early radiation effects under verum than under placebo (U3 vs U6: p < 0.05, area under curve: p = 0.032; Table 2, Figure 3). The scintigraphically determined excretion fraction was slightly less impaired in the verum group compared to the placebo treatment (p = 0.12. Figure 4). There was no difference in drug safety between placebo and verum for adverse events, changes in the activity of liver enzymes and for global impression of tolerability. CONCLUSIONS: The results give support for an advantageous effect of Venalot Depot in the treatment of radiogenic sialadenitis and mucositis. In even a small number of evaluable patients, early clinical effects of irradiation (RTOG-score) were less pronounced in the active treatment group than in the placebo group, but the sample size was too low to prove statistically also the benefit of coumarin/troxerutine with the scintigraphic method. Sialometry seems not suitable for the assessment of early radiation effects.

Adult↗