TheranosticTrials.org

Clinical Trial · NCT02134639

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

Overview

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.

Sponsor

University Hospital, Bordeaux

Phase

Phase 1

Contacts

Philippe FERNANDEZ, Professor (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02134639

Drug / Compound

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

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

Exclusion

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