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

Paragangliomas Clinical Trial

— DOTATATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186678
• Other study ID #: 2013-26
• Status: Completed
• Phase: N/A
• Start date: July 18, 2014
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 5, 2023
• Est. primary completion date: October 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraganglioma
• Paragangliomas
• Pheochromocytoma
• Pheochromocytomas

Intervention

Other:
• PET-CT

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assesment of 68Ga-DOTATATE PET-CT to anatomical imaging	The third objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning the genetic status,	7 months
Other	assesment of 68Ga-DOTATATE PET-CT to anatomical imaging	The fourth objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning Somatostatin receptor expression	7 months
Primary	interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL	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.	7 months
Secondary	assesment of 68Ga-DOTATATE PET-CT to anatomical imaging	The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location	7 months