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

NCT ID: NCT02134639

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient who is suspected of endocrine tumors

According to symptomatology, biology or imaging or pathological context

68Ga-DOTATOC PET-CT Imaging

Intervention Type: PROCEDURE

Interventions

68Ga-DOTATOC PET-CT Imaging

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe FERNANDEZ, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

2013-003927-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CHUBX2012/28

Identifier Type: -

Identifier Source: org_study_id