d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
July 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2019
CompletedResults Posted
Study results publicly available
October 20, 2020
CompletedOctober 20, 2020
September 1, 2020
1.2 years
May 25, 2018
September 3, 2020
September 25, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake
3 days
18FDG Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
2 days
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
2 days
Secondary Outcomes (2)
Physician Confidence in Study Interpretation
2 days
Subject Satisfaction
2 days
Study Arms (1)
68Ga-DOTATATE PET/CT
EXPERIMENTAL68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
Interventions
5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
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.
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)
You may not qualify if:
- Pregnant
- Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Limitations and Caveats
Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans
Results Point of Contact
- Title
- John P. Bois, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
John P Bois
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 8, 2018
Study Start
July 20, 2018
Primary Completion
October 2, 2019
Study Completion
October 2, 2019
Last Updated
October 20, 2020
Results First Posted
October 20, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share