PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation (GALTEP)

University Hospital of Bordeaux

Status: Completed

Conditions: Neuroendocrine Tumors

Treatments: Procedure: 68Ga-DOTATOC PET-CT Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02134639

2013-003927-12 (EudraCT Number)

CHUBX2012/28

Details and patient eligibility

About

Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years
• Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
• initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
• Search of the primary tumor, especially in the case of the inaugural discovery of metastases
• staging of a known recurrence
• Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
• Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
• Patient who have signed an informed consent
• Patient affiliated or beneficiary of regime of social security of a Member State of the European community

Exclusion criteria

• Patient with another evolutive cancer disease and/or treated for less than 5 years
• Pregnant or lactating woman
• Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
• Patient unable to give their free and informed consent
• Persons placed under judicial protection

Trial design

20 participants in 1 patient group

Patient who is suspected of endocrine tumors

Description:

According to symptomatology, biology or imaging or pathological context

Treatment:

Procedure: 68Ga-DOTATOC PET-CT Imaging