The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas. In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning.
Name: 177Lu-PP-F11N
Description: Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).
Measure: Phase 0: Scintigraphic visualisation rate Time: up to 4 weeksDescription: Phase I study: Determination of the maximum tolerated dose (MTD)
Measure: Phase I: Maximum tolerated dose Time: Up to 9 monthsDescription: Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
Measure: Phase 0: Tumour-to-kidney radiation doses Time: 8 and 16 weeksDescription: Calculation of tumour and organ radiation doses.
Measure: Phase 0: Radiation doses Time: 8 and 16 weeksDescription: Evaluation of in vivo stability of 177Lu-PP-F11N.
Measure: Phase 0: In vivo stability Time: 8 and 16 weeksDescription: Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
Measure: Phase 0: Metabolites Time: 8 and 16 weeksDescription: Evaluation of side reactions of 177Lu-PP-F11N.
Measure: Phase I: Side reactions Time: 8, 16 and 24 weeksDescription: Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
Measure: Phase 1: Biochemical response Time: For the duration of 24 months.Description: Evaluation of morphological therapy response (RECIST criteria).
Measure: Phase I: Morphological response Time: 0, 3 and 12 monthsDescription: Determination of the tumour detection rate and correlation with surgery/histology, if possible.
Measure: Phase I: Tumour detection rate Time: 8, 16 and 24 weeksDescription: Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
Measure: Phase I: Organ radiation doses Time: 8, 16 and 24 weeksDescription: Determination of overall survival of patients after therapy.
Measure: Phase 1: Overall survival Time: Up to 5 yearsDescription: Evaluation of in vivo stability of 177Lu-PP-F11N.
Measure: Phase 1: In vivo stability Time: 8, 16 und 24 weeksDescription: Measurement of the metabolites of 177Lu-PP-F11N.
Measure: Phase 1: Metabolites Time: 8, 16 and 24 weeksAllocation: N/A
Single Group Assignment
There is one SNP
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.. 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer. --- F11N ---
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.. 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer. --- F11N --- --- F11N ---
The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). --- F11N ---
177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. --- F11N ---
In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. --- F11N ---
Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).. Phase I: Maximum tolerated dose. --- F11N ---
Evaluation of in vivo stability of 177Lu-PP-F11N.. Phase 0: Metabolites. --- F11N ---
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.. Phase I: Side reactions. --- F11N ---
Evaluation of side reactions of 177Lu-PP-F11N.. Phase 1: Biochemical response. --- F11N ---
Evaluation of in vivo stability of 177Lu-PP-F11N.. Phase 1: Metabolites. --- F11N ---
Measurement of the metabolites of 177Lu-PP-F11N.. Inclusion Criteria: Phase 0 study - Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy - Age > 18 years - Informed consent Phase I study - Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks - Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years - Informed consent - Curative surgical therapy not possible Exclusion Criteria: Phase 0 study - Medication with Vandetanib 3 weeks before the study and during the study - Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface). --- F11N ---