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. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
University Hospital Basel, Clinic for radiology and nuclear medicine
Basel, Switzerland
Phase 0: Scintigraphic visualisation rate
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).
Time frame: up to 4 weeks
Phase I: Maximum tolerated dose
Phase I study: Determination of the maximum tolerated dose (MTD)
Time frame: Up to 9 months
Phase 0: Tumour-to-kidney radiation doses
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
Time frame: 8 and 16 weeks
Phase 0: Radiation doses
Calculation of tumour and organ radiation doses.
Time frame: 8 and 16 weeks
Phase 0: In vivo stability
Evaluation of in vivo stability of 177Lu-PP-F11N.
Time frame: 8 and 16 weeks
Phase 0: Metabolites
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
Time frame: 8 and 16 weeks
Phase I: Side reactions
Evaluation of side reactions of 177Lu-PP-F11N.
Time frame: 8, 16 and 24 weeks
Phase 1: Biochemical response
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
Time frame: For the duration of 24 months.
Phase I: Morphological response
Evaluation of morphological therapy response (RECIST criteria).
Time frame: 0, 3 and 12 months
Phase I: Tumour detection rate
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
Time frame: 8, 16 and 24 weeks
Phase I: Organ radiation doses
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
Time frame: 8, 16 and 24 weeks
Phase 1: Overall survival
Determination of overall survival of patients after therapy.
Time frame: Up to 5 years
Phase 1: In vivo stability
Evaluation of in vivo stability of 177Lu-PP-F11N.
Time frame: 8, 16 und 24 weeks
Phase 1: Metabolites
Measurement of the metabolites of 177Lu-PP-F11N.
Time frame: 8, 16 and 24 weeks
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