Clinical trial NCT02587247: ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
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
Secondary outcomes:
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: Month 3
measure: 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.
timeFrame: Month 3
measure: To assess the safety of the procedure
timeFrame: Month 3
measure: Search for the development of a blood Immunization against the products
timeFrame: Month 3
measure: To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
timeFrame: No more than 3 months (it depend of the day of the surgery)
measure: To evaluate the clinical impact (new lecture of imaging, new examens)
timeFrame: M1
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU
city: Saint Herblain
country: France
facility: Institut de cancérologie de l'Ouest
Study officials:
References:
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.