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Le groupe d'étude des tumeurs endocrines est une société savante créée en 2002 réunissant les différentes spécialités impliquées dans la prise en charge des tumeurs neuro-endocrines (TNE) : anatomopathologistes, biologistes, chirurgiens, endocrinologues, gastroentérologues, généticiens, médecins nucléaires, oncologues et radiologues.

ITEP-CMT

ImmunoTEP for Patients With Medullary Thyroid Carcinoma

Type d'étude Promoteur Etat actuel de l'étude 1ère présentation
au congrès
Principale publication
Phase I-II CHU Nantes Terminée aux inclusions   Bodet-Milin , J Nucl Med. - 2016

 

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.

Code de l’étude

iTEP-CMT

Promoteur

CHU de Nantes

Tumeur éligible

Cancer médullaire de la thyroïde

Type d’étude

Interventionnelle, monobras, radiopharmaceutique à l’essai : TF2 et 68 Ga-IMP-288

Phase

Phase I et II

Nombre de patients à inclure

 

Contact

Françoise Bodere, MD  Mail Bodere

Investigateur(s)

Françoise Bodere, Olivier Couturier (Angers), Caroline Rousseau (institut Gauducheau)

Centres

CHU Nantes, Institut de cancérologie René Gauducheau Nantes, CHU d’Angers

Objectifs

Evaluation of the tumor targeting and signal/noise ratio by immunoTEP with TF2 and 68-Ga-IMP-288

Critères d’inclusion

• 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

Critères d’exclusion

• 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