Trial Outcomes & Findings for d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis (NCT NCT03549598)

Results Overview

The number of subjects with areas of abnormal myocardial increased focal uptake

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

3 days

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	68Ga-DOTATATE PET/CT 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route. 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol. 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-DOTATATE PET/CT n=15 Participants 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route. 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol. 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
Age, Continuous	70 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Population: Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data not obtained and was not analyzed

The number of subjects with areas of abnormal myocardial increased focal uptake

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 days

The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan

Outcome measures

Outcome measures
Measure	68Ga-DOTATATE PET/CT n=15 Participants 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route. 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol. 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
18FDG Uptake With Cardia Sarcoidosis (CS)	9 Participants

PRIMARY outcome

Timeframe: 2 days

The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan

Outcome measures

Outcome measures
Measure	68Ga-DOTATATE PET/CT n=15 Participants 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route. 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol. 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)	8 Participants

SECONDARY outcome

Timeframe: 2 days

Population: Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data unable to obtain and was not analyzed

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	68Ga-DOTATATE PET/CT n=15 Participants 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route. 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol. 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
Subject Satisfaction 18FDG	0 Participants
Subject Satisfaction 68GA-DOTATATE	13 Participants
Subject Satisfaction Equal	2 Participants

Adverse Events

68Ga-DOTATATE PET/CT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

18FDG PET/CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

13NH3 PET/CT"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	68Ga-DOTATATE PET/CT n=15 participants at risk 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.	18FDG PET/CT n=15 participants at risk 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.	13NH3 PET/CT" n=15 participants at risk 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject 13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • Adverse events were collected from baseline to through end of study (completion of last scan), approximately 3 days	0.00% 0/15 • Adverse events were collected from baseline to through end of study (completion of last scan), approximately 3 days	0.00% 0/15 • Adverse events were collected from baseline to through end of study (completion of last scan), approximately 3 days

Additional Information

John P. Bois, M.D.

Mayo Clinic

Phone: 507-284-3545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place