ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587247
• Other study ID #: RC14_0428
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• TF2 antibody/68Ga-IMP-288
TF2 antibody coupled with 68Ga-IMP-288

Locations

Country	Name	City	State
France	CHU	Nantes
France	Institut de cancérologie de l'Ouest	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Month 3
Secondary	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	Month 3
Secondary	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	Month 3
Secondary	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	Month 3
Secondary	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	No more than 3 months (it depend of the day of the surgery)
Secondary	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	M1