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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
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
John P. Bois, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cardiac Sarcoidosis Drug: 68Ga-DOTATATE PET/CT Drug: 18FDG PET/CT scan Drug: 13NH3 PET/CT scan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : October 2, 2019
Actual Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: 68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT and 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed
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.




Primary Outcome Measures :
  1. 68Ga-DOTATATE uptake with Cardia Sarcoidosis (CS) [ Time Frame: 3 days ]
    The number of areas of abnormal myocardial increased focal uptake

  2. 18FDG uptake with Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of areas of abnormal myocardial increased focal uptake

  3. 13NH3 PET/CT uptake with Cardia Sarcoidosis (CS) [ Time Frame: 2 days ]
    The number of areas of perfusion deficits


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549598


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John P Bois Mayo Clinic
Additional Information:
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Responsible Party: John P. Bois, M.D., Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03549598    
Other Study ID Numbers: 18-000393
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action