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ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

Sponsored by Nantes University Hospital

About this trial

Last updated 3 years ago

Study ID

PROG/10/94

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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