Clinical trial NCT01730638: ImmunoTEP for Patients With Medullary Thyroid Carcinoma.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Medullary Thyroid Carcinoma
Keywords: thyroid,
endocrine tumour
Nuclear medicine,
molecular imaging
ImmunoTEP
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Gilead Sciences
First posted: 2012-11-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
timeFrame: one week
Secondary outcomes:
measure: Sensibilité
timeFrame: 6 monts after immunoTEP
Other outcomes:
measure: tolerance
timeFrame: 6 monts after immunoTEP
measure: a second _iTEP if necessary for the follow up of a lesion
timeFrame: 6 monts after immunoTEP
Locations:
city: Angers
country: France
facility: Angers Hospital
city: Nantes
country: France
facility: Nantes Hospital
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'ouest, René Gauducheau
Study officials:
affiliation: Nantes Hospital
name: Francoise Bodere, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: