ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

Study Overview
=================
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.

Official Title
-----------------
Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.

Conditions
-----------------
Medullary Thyroid Carcinoma

Intervention / Treatment
-----------------
* Drug: • TF2 and 68 Ga-IMP-288


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TF2 antibody/68Ga-IMP-288<br>TF2 coupled with 68 Ga-IMP-288 | Drug: • TF2 and 68 Ga-IMP-288<br> <br> * Other names: • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288 | Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibilité |  | 6 monts after immunoTEP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP