Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to
investigate the IMP, namely 111In-CP04.
The study consists of preclinical (to establish a clinically useful formulation for the
radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of
the project is to establish the safety of i.v. administration of a high peptide amount and to
assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine
critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to
detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of
kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To
achieve this, the following study design has been accepted: the first 4 patients will receive
2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount
(for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized
for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.
It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for
a specific non-invasive staging and follow-up of patients with MTC, and treatment of
recurrent and disseminated disease will be more efficient with minimized nephro- and
myelotoxicity (if 111In labelled).
Phase:
Phase 1
Details
Lead Sponsor:
Paola Anna Erba
Collaborators:
Erasmus Medical Center INRASTES, NCSR Demokritos, Athens, Greece Jagiellonian University Medical University Innsbruck NATIONAL CENTRE FOR NUCLEAR RESEARCH, Poland University Hospital Freiburg University Medical Centre Ljubljana