Medullary Thyroid Carcinoma
Conditions
Keywords
thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP
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.
Interventions
DRUG• TF2 and 68 Ga-IMP-288
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Gilead Sciences
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Sensibilité | 6 monts after immunoTEP |
Other
| Measure | Time frame | Description |
|---|---|---|
| a second _iTEP if necessary for the follow up of a lesion | 6 monts after immunoTEP | with in the follow up of the pateint |
| tolerance | 6 monts after immunoTEP | — |
Countries
France
Outcome results
None listed