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

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Procedure: 68Ga-DOTATOC PET-CT Imaging

• Registration Number: NCT02134639
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who is suspected of endocrine tumors	68Ga-DOTATOC PET-CT Imaging	According to symptomatology, biology or imaging or pathological context

Primary Outcome Measures

Name	Time	Method
Evaluation of PET imaging	Inclusion (day 0)	The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up.

Secondary Outcome Measures

Name	Time	Method
Impact on the therapeutic management	End of follow up (day 28)	The impact on the therapeutic management of patients will be studied by the analysis of questionnaires with or without taking into account, the results of the PET-CT with 68Ga-DOTATOC.
Reproducibility	Inclusion (day 0)	The reproducibility of the new method of radiolabelling will be evaluated by the number of failed syntheses
Tolerance	Inclusion (day 0) and until end of follow up (day 28)	Tolerance of the tracer will be assessed by the collection of possible side effects

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France