Back to resultsd68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Primary Purpose
Cardiac Sarcoidosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
68Ga-DOTATATE PET/CT
18FDG PET/CT scan
13NH3 PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Sarcoidosis
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-DOTATATE PET/CT
Arm Description
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Outcomes
Primary Outcome Measures
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake
18FDG Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Secondary Outcome Measures
Physician Confidence in Study Interpretation
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03549598
Brief Title
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Official Title
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Sarcoidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTATATE PET/CT
Arm Type
Experimental
Arm Description
68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTATATE PET/CT
Intervention Description
5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
Intervention Type
Drug
Intervention Name(s)
18FDG PET/CT scan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
13NH3 PET/CT scan
Intervention Description
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 Measure Information:
Title
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Description
The number of subjects with areas of abnormal myocardial increased focal uptake
Time Frame
3 days
Title
18FDG Uptake With Cardia Sarcoidosis (CS)
Description
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
Time Frame
2 days
Title
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
Description
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Physician Confidence in Study Interpretation
Description
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
Time Frame
2 days
Title
Subject Satisfaction
Description
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
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Bois
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
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