d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Phase 4

Completed

• Conditions: Cardiac Sarcoidosis
• Interventions: Drug: 68Ga-DOTATATE PET/CT; Drug: 18FDG PET/CT scan; Drug: 13NH3 PET/CT scan

• Registration Number: NCT03549598
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Study Start: 2018-07-20
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-02
• Status Verified: 2020-09
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Results First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTATATE PET/CT	68Ga-DOTATATE PET/CT	68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
68Ga-DOTATATE PET/CT	18FDG PET/CT scan	68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject
68Ga-DOTATATE PET/CT	13NH3 PET/CT scan	68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

Primary Outcome Measures

Name	Time	Method
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)	3 days	The number of subjects with areas of abnormal myocardial increased focal uptake
18FDG Uptake With Cardia Sarcoidosis (CS)	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)	2 days	The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan

Secondary Outcome Measures

Name	Time	Method
Physician Confidence in Study Interpretation	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	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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States