Back to resultsComparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation (DOTATATE)
Primary Purpose
Paragangliomas, Pheochromocytomas
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Paragangliomas
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
assesment by 68Ga-DOTATATE PET-CT
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02186678
First Posted
June 4, 2014
Last Updated
April 5, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02186678
Brief Title
Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2014 (Actual)
Primary Completion Date
October 5, 2015 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paragangliomas, Pheochromocytomas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
assesment by 68Ga-DOTATATE PET-CT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PET-CT
Primary Outcome Measure Information:
Title
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
Description
The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location
Time Frame
7 months
Other Pre-specified Outcome Measures:
Title
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
Description
The third objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning the genetic status,
Time Frame
7 months
Title
assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
Description
The fourth objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning Somatostatin receptor expression
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David TAIEB, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
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