Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation

Not Applicable

Completed

• Conditions: Paragangliomas; Pheochromocytomas
• Interventions: Other: PET-CT

• Registration Number: NCT02186678
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Study Start: 2014-07-18
• Primary Completion: 2015-10-05
• Status Verified: 2023-04
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
assesment by 68Ga-DOTATATE PET-CT	PET-CT	-

Primary Outcome Measures

Name	Time	Method
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL	7 months	The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.

Secondary Outcome Measures

Name	Time	Method
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging	7 months	The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France