Skip to main content
OpenTrials
Completed

NCT Number: NCT02587247

ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU, Nantes, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TF2 antibody/68Ga-IMP-288

Drug

TF2 antibody coupled with 68Ga-IMP-288

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: iTEP Colon

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.