Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC

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).

Conditions

• Medullary Thyroid Carcinoma

Interventions

DRUG

111In-CP04

Radiopharmaceutical preparation

DRUG

111In-CP04 with co-administration of gelofusine/gelaspan

Radiopharmaceutical preparation with co-administration of gelofusine/gelaspan

Sponsors & Collaborators

• Jagiellonian University

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• University Medical Centre Ljubljana

  collaborator OTHER

• NATIONAL CENTRE FOR NUCLEAR RESEARCH, Poland

  collaborator UNKNOWN

• Erasmus Medical Center

  collaborator OTHER

• INRASTES, NCSR Demokritos, Athens, Greece

  collaborator UNKNOWN

• Paola Anna Erba

  lead OTHER

Principal Investigators

• Paola Anna Erba, Professor · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-11-30

Completion

2018-11-30

Countries

• Austria
• Germany
• Netherlands
• Poland
• Slovenia

Study Locations