Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
DOTATATE
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
July 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2023
CompletedApril 6, 2023
April 1, 2023
1.2 years
June 4, 2014
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
7 months
Other Outcomes (2)
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
7 months
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
7 months
Study Arms (1)
assesment by 68Ga-DOTATATE PET-CT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or breast-feeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13005, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David TAIEB, MD
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
July 10, 2014
Study Start
July 18, 2014
Primary Completion
October 5, 2015
Study Completion
April 5, 2023
Last Updated
April 6, 2023
Record last verified: 2023-04