ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

NCT ID: NCT01730638

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

Brief Summary

The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

Detailed Description

Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.

A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.

some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.

Conditions

Medullary Thyroid Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TF2 antibody/68Ga-IMP-288

TF2 coupled with 68 Ga-IMP-288

Group Type: EXPERIMENTAL

• TF2 and 68 Ga-IMP-288

Intervention Type: DRUG

Interventions

• TF2 and 68 Ga-IMP-288

Intervention Type: DRUG

Other Intervention Names

• TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG); • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of CMT
• Calcitonin> 150 pg / ml
• Complete treatment of the primary tumor
• at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
• Age ≥ 18 years
• Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
• KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
• Absence of serious illness or co-morbidity assessed risk
• Creatinine ≤ 2.5 normal
• Absence of cancer treatment within 6 weeks prior to the immuno-PET
• No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
• Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
• Informed consent signed
• Social Insurance

Exclusion Criteria

• Pregnancy or breastfeeding
• Serious illness or co-morbidity assessed risk
• History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
• Presence of anti-antibodies in patients who have previously received antibodies
• Known hypersensitivity to antibody or protein
• Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
• Inability intellectual sign consent
• Patient protected by law

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francoise Bodere, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes Hospital

Locations

Angers Hospital

Angers, , France

Nantes Hospital

Nantes, , France

Institut de Cancérologie de l'ouest, René Gauducheau

Saint-Herblain, , France

Countries

France

Other Identifiers

PROG/10/94

Identifier Type: -

Identifier Source: org_study_id