Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation (DOTATATE)
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|ClinicalTrials.gov Identifier: NCT02186678|
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Paragangliomas Pheochromocytomas||Other: PET-CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||February 2018|
|Experimental: assesment by 68Ga-DOTATATE PET-CT||
- interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL [ Time Frame: 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.
- assesment of 68Ga-DOTATATE PET-CT to anatomical imaging [ Time Frame: 7 months ]The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location
- assesment of 68Ga-DOTATATE PET-CT to anatomical imaging [ Time Frame: 7 months ]The third objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning the genetic status,
- assesment of 68Ga-DOTATATE PET-CT to anatomical imaging [ Time Frame: 7 months ]The fourth objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning Somatostatin receptor expression
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186678
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13005|
|Principal Investigator:||David TAIEB, MD||Assistance Publique Hopitaux De Marseille|