ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
- Conditions
- Medullary Thyroid Carcinoma
- Interventions
- Drug: • TF2 and 68 Ga-IMP-288
- Registration Number
- NCT01730638
- Lead Sponsor
- Nantes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TF2 antibody/68Ga-IMP-288 • TF2 and 68 Ga-IMP-288 TF2 coupled with 68 Ga-IMP-288
- Primary Outcome Measures
Name Time Method Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288 one week 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.
- Secondary Outcome Measures
Name Time Method Sensibilité 6 monts after immunoTEP
Trial Locations
- Locations (3)
Nantes Hospital
🇫🇷Nantes, France
Angers Hospital
🇫🇷Angers, France
Institut de Cancérologie de l'ouest, René Gauducheau
🇫🇷Saint-Herblain, France