ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)

July 22, 2022 updated by: Nantes University Hospital

Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.

The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.

A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.

some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Angers Hospital
      • Nantes, France, 44100
        • Nantes Hospital
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest, René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological diagnosis of CMT
  • Calcitonin> 150 pg / ml
  • Complete treatment of the primary tumor
  • at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
  • Age ≥ 18 years
  • Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
  • KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
  • Absence of serious illness or co-morbidity assessed risk
  • Creatinine ≤ 2.5 normal
  • Absence of cancer treatment within 6 weeks prior to the immuno-PET
  • No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
  • Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
  • Informed consent signed
  • Social Insurance

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Serious illness or co-morbidity assessed risk
  • History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
  • Presence of anti-antibodies in patients who have previously received antibodies
  • Known hypersensitivity to antibody or protein
  • Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
  • Inability intellectual sign consent
  • Patient protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TF2 antibody/68Ga-IMP-288
TF2 coupled with 68 Ga-IMP-288
Drug: • TF2 and 68 Ga-IMP-288
Other Names:
  • • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
  • • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
Time Frame: one week

Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart.

A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
one week

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensibilité
Time Frame: 6 monts after immunoTEP
6 monts after immunoTEP

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
tolerance
Time Frame: 6 monts after immunoTEP
6 monts after immunoTEP
a second _iTEP if necessary for the follow up of a lesion
Time Frame: 6 monts after immunoTEP
with in the follow up of the pateint
6 monts after immunoTEP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Gilead Sciences

Investigators

  • Principal Investigator: francoise Bodere, PhD, MD, Nantes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROG/10/94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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