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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE June 4, 2014
First Posted Date  ICMJE July 10, 2014
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
Official Title  ICMJE Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Paragangliomas
  • Pheochromocytomas
Intervention  ICMJE Other: PET-CT
Study Arms  ICMJE Experimental: assesment by 68Ga-DOTATATE PET-CT
Intervention: Other: PET-CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02186678
Other Study ID Numbers  ICMJE 2013-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David TAIEB, MD Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP