ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer (iTEP Colon)

July 22, 2022 updated by: Nantes University Hospital

Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel

Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

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
      • Nantes, France, 44093
        • CHU
      • Saint Herblain, France, 44805
        • Institut de cancerologie de l'ouest

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:

  • Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse.

OR

  • Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk
  • More than 18 years
  • Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months.
  • At least 4 weeks after the last treatment and after recovery of potential toxicity
  • Karnofsky more than 70 or ECOG 0-1
  • Life expectancy of at least 6 months
  • CEA positive immunohistochemistry or plasma CEA supperior or equal to the normal level
  • Creatinin less or equal 200 micromol/L
  • Signed informed consent
  • geographical proximity

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Serious illness or comorbidity assessed risk
  • History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix
  • Anti-antibody presence in patients who have already received antibody
  • Hypersensitivity to antibodies or proteins
  • Intellectual inability to sign the informed consent
  • Insulin-dependent diabetic patient or non-insulin dependent

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
Drug: TF2 antibody/68Ga-IMP-288
TF2 antibody coupled with 68Ga-IMP-288

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68
Time Frame: Month 3
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the diagnostic performance of immuno-PET with morphological and functional imaging procedures currently performed in the imaging assessment (CT, ultrasound + liver MRI, FDG-PET).
Time Frame: Month 3
Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET
Month 3
To Determine the value of immuno-PET in terms of specificity and predictive value. This determination will be made at the "patient" and at the "injury level.
Time Frame: Month 3
Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation
Month 3
To assess the safety of the procedure
Time Frame: Month 3
Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria
Month 3
Search for the development of a blood Immunization against the products
Time Frame: Month 3
Human anti Human antibody test by immuno assay at base line, M1 and M3
Month 3
To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
Time Frame: No more than 3 months (it depend of the day of the surgery)
Immunohistochemistry analysis with anti CEA antibody
No more than 3 months (it depend of the day of the surgery)
To evaluate the clinical impact (new lecture of imaging, new examens)
Time Frame: M1
A form will be fill in by the physican who request the immuno PET
M1

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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