Clinical trial · Interventional
ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TF2 antibody/68Ga-IMP-288
- description
- TF2 antibody/68Ga-IMP-288
- interventionNames
- Drug: TF2 antibody/68Ga-IMP-288
Primary outcomes (1)
- measure
- 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
- timeFrame
- Month 3
- description
- Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
Secondary outcomes (6)
- measure
- 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).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTouchefeu 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 32820369