PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Conditions
Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Endocrine Gland Neoplasms - Neuroendocrine Tumors
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: 68Ga-DOTATOC PET-CT Imaging
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
CHU de Bordeaux
Bordeaux, France
Status: Recruiting
Contact: Philippe FERNANDEZ, Professor - 05-56-79-55-40 - philippe.fernandez@u-bordeaux2.fr
Start Date
September 2014
Completion Date
September 2015
Sponsors
University Hospital, Bordeaux
Source
University Hospital, Bordeaux
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page