Clinical trial NCT02134639: PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Official title: Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who is suspected of endocrine tumors

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.


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

Primary outcomes:
measure: Evaluation of PET imaging
timeFrame: Inclusion (day 0)
Secondary outcomes:
measure: Reproducibility
timeFrame: Inclusion (day 0)
measure: Tolerance
timeFrame: Inclusion (day 0) and until end of follow up (day 28)
measure: Impact on the therapeutic management
timeFrame: End of follow up (day 28)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Philippe FERNANDEZ, Professor
role: PRINCIPAL_INVESTIGATOR
References: