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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
TF2 antibody/68Ga-IMP-288
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • Institut de cancérologie de l'Ouest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TF2 antibody/68Ga-IMP-288

Arm Description

TF2 antibody/68Ga-IMP-288

Outcomes

Primary Outcome Measures

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
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry

Secondary Outcome Measures

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).
Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET
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.
Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation
To assess the safety of the procedure
Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria
Search for the development of a blood Immunization against the products
Human anti Human antibody test by immuno assay at base line, M1 and M3
To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
Immunohistochemistry analysis with anti CEA antibody
To evaluate the clinical impact (new lecture of imaging, new examens)
A form will be fill in by the physican who request the immuno PET

Full Information

First Posted
October 19, 2015
Last Updated
July 22, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02587247
Brief Title
ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer
Acronym
iTEP Colon
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TF2 antibody/68Ga-IMP-288
Arm Type
Experimental
Arm Description
TF2 antibody/68Ga-IMP-288
Intervention Type
Drug
Intervention Name(s)
TF2 antibody/68Ga-IMP-288
Intervention Description
TF2 antibody coupled with 68Ga-IMP-288
Primary Outcome Measure Information:
Title
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
Description
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
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).
Description
Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET
Time Frame
Month 3
Title
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.
Description
Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation
Time Frame
Month 3
Title
To assess the safety of the procedure
Description
Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria
Time Frame
Month 3
Title
Search for the development of a blood Immunization against the products
Description
Human anti Human antibody test by immuno assay at base line, M1 and M3
Time Frame
Month 3
Title
To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
Description
Immunohistochemistry analysis with anti CEA antibody
Time Frame
No more than 3 months (it depend of the day of the surgery)
Title
To evaluate the clinical impact (new lecture of imaging, new examens)
Description
A form will be fill in by the physican who request the immuno PET
Time Frame
M1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Institut de cancérologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32820369
Citation
Touchefeu Y, Bailly C, Frampas E, Eugene T, Rousseau C, Bourgeois M, Bossard C, Faivre-Chauvet A, Rauscher A, Masson D, David A, Cerato E, Carlier T, Sharkey RM, Goldenberg DM, Barbet J, Kraeber-Bodere F, Bodet-Milin C. Promising clinical performance of pretargeted immuno-PET with anti-CEA bispecific antibody and gallium-68-labelled IMP-288 peptide for imaging colorectal cancer metastases: a pilot study. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):874-882. doi: 10.1007/s00259-020-04989-3. Epub 2020 Aug 21.
Results Reference
derived

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ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

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