d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Cardiac Sarcoidosis Clinical Trial

Official title:

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549598
• Other study ID #: 18-000393
• Status: Completed
• Phase: Phase 4
• Start date: July 20, 2018
• Est. completion date: October 2, 2019

Study information

• Verified date: September 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Intervention

Drug:
• 68Ga-DOTATATE PET/CT
5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)	The number of subjects with areas of abnormal myocardial increased focal uptake	3 days
Primary	18FDG Uptake With Cardia Sarcoidosis (CS)	The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan	2 days
Primary	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	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	2 days
Secondary	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	2 days

External Links

•   Mayo Clinic Clinical Trials