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d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549598
Recruitment Status : Completed
First Posted : June 8, 2018
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
John P. Bois, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 8, 2018
Results First Submitted Date  ICMJE September 3, 2020
Results First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE July 20, 2018
Actual Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
  • 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 3 days ]
    The number of subjects with areas of abnormal myocardial increased focal uptake
  • 18FDG Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
  • 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 3 days ]
    The number of areas of abnormal myocardial increased focal uptake
  • 18FDG Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of areas of abnormal myocardial increased focal uptake
  • 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of areas of perfusion deficits
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
  • Physician Confidence in Study Interpretation [ Time Frame: 2 days ]
    A Physician survey will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other
  • Subject Satisfaction [ Time Frame: 2 days ]
    A patient survey will be conducted after each subject has undergone both the DOTATE and the FDG scans. Patient satisfaction will be measured by the question, "Which study did you prefer?" Subject to circle one of the following: 18FDG, 68Ga-DOTATATE or Equal
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Physician Confidence in Study Interpretation [ Time Frame: 2 days ]
    Physician surveys will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other
  • Patient Satisfaction [ Time Frame: 2 days ]
    Patient surveys will be conducted after they have undergone both the DOTATE and the FDG studies to assess which study protocol they preferred.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Official Title  ICMJE d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Brief Summary The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.
Detailed Description Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cardiac Sarcoidosis
Intervention  ICMJE
  • Drug: 68Ga-DOTATATE PET/CT
    5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
  • Drug: 18FDG PET/CT scan
    This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
  • Drug: 13NH3 PET/CT scan
    This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
Study Arms  ICMJE Experimental: 68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Interventions:
  • Drug: 68Ga-DOTATATE PET/CT
  • Drug: 18FDG PET/CT scan
  • Drug: 13NH3 PET/CT scan
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2, 2019
Actual Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion Criteria:

  • Pregnant
  • Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549598
Other Study ID Numbers  ICMJE 18-000393
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John P. Bois, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John P Bois Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2020

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