ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
Conditions
Medullary Thyroid Carcinoma
Conditions: official terms
Carcinoma - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
thyroid,, endocrine tumour, Nuclear medicine,, molecular imaging, ImmunoTEP
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: • TF2 and 68 Ga-IMP-288
Type: Drug
Overall Status
Recruiting
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 to 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Angers Hospital
Angers, France
Status: Recruiting
Contact: Olivier Couturier, PhD, MD - ocouturier70@me.com
Nantes Hospital
Nantes, France
Status: Recruiting
Contact: françoise Bodere, PhD, MD - 00320240084136 - francoise.bodere@chu-nantes.fr
Institut de Cancérologie de l'ouest, René Gauducheau
Sant Herblain, France
Status: Recruiting
Contact: Caroline Rousseau, PhD, MD - 0032240679931 - "evelyne.cerato@chu-nantes.fr" <evelyne.cerato@chu-nantes.fr>
Start Date
January 2013
Completion Date
June 2015
Sponsors
Nantes University Hospital
Source
Nantes University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page