This trial is active, not recruiting.

Conditions paragangliomas, pheochromocytomas
Treatment pet-ct
Sponsor Assistance Publique Hopitaux De Marseille
Start date July 2014
End date July 2017
Trial size 30 participants
Trial identifier NCT02186678, 2013-26


18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.

In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
time frame: 7 months

Secondary Outcomes

assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
time frame: 7 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: Age ≥ 18 - PHEO or PGL: initial staging or restaging - Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization Exclusion Criteria: Pregnant or breast-feeding woman

Additional Information

Official title Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
Principal investigator David TAIEB, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.