ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborators: Gilead Sciences; Immunomedics, Inc.; Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Antibodies; Glycine; Histamine

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