NCT02587247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

October 19, 2015

Last Update Submit

July 22, 2022

Conditions

Metastatic Colorectal Cancer

Outcome Measures

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

    Initial and M3 imaging assessment comparaison, and/or immunohistochemistry

    Month 3

Secondary Outcomes (6)

  • 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).

    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.

    Month 3

  • To assess the safety of the procedure

    Month 3

  • Search for the development of a blood Immunization against the products

    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

    No more than 3 months (it depend of the day of the surgery)

  • +1 more secondary outcomes

Study Arms (1)

TF2 antibody/68Ga-IMP-288

EXPERIMENTAL

TF2 antibody/68Ga-IMP-288

Drug: TF2 antibody/68Ga-IMP-288

Interventions

TF2 antibody/68Ga-IMP-288DRUG

TF2 antibody coupled with 68Ga-IMP-288

TF2 antibody/68Ga-IMP-288

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU

Nantes, 44093, France

Location

Institut de cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Related Publications (1)

  • 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.

    PMID: 32820369DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 27, 2015

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)