Phase 4
N=15
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Cardiac Sarcoidosis
Bottom Line
View on ClinicalTrials.gov: NCT03549598 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 68Ga-DOTATATE PET/CT (Drug); 18FDG PET/CT scan (Drug); 13NH3 PET/CT scan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) |
— | — |
| PRIMARY 18FDG Uptake With Cardia Sarcoidosis (CS) |
9 | — |
| PRIMARY 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) |
8 | — |
| SECONDARY Physician Confidence in Study Interpretation |
— | — |
| SECONDARY Subject Satisfaction |
0; 13; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03549598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.