Trial Outcomes & Findings for 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation (NCT NCT03103490)

Last Updated: 2023-04-07

Results Overview

Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-FSPG uptake will be considered to be positive findings indicating cardiac involvement of sarcoidosis or inflammation

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

average approximately 2 hours

Results posted on

2023-04-07

Participant Flow

45 participants signed consent; 28 were allocated to the study arm.

Participant milestones

Participant milestones
Measure	18F-FSPG Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation using PET/MRI (or PET/CT for patients with metal implants).
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-FSPG n=28 Participants Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation using PET/MRI (or PET/CT for patients with metal implants).
Age, Continuous	59.0 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	4 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: average approximately 2 hours

Outcome measures

Outcome measures
Measure	18F-FSPG n=28 Participants Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation using PET/MRI (or PET/CT for patients with metal implants).
Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis	2 Participants

SECONDARY outcome

Timeframe: average approximately 2 hours

The whole-body PET/MRI images will be evaluated for findings of extra-cardiac sarcoidosis. Evidence of 18F-FSPG uptake within the whole body will indicate a positive finding for the presence of extra-cardiac sarcoidosis.

Outcome measures

Outcome measures
Measure	18F-FSPG n=28 Participants Patients receive 18F-FSPG for detection of Cardiac Sarcoidosis or Inflammation using PET/MRI (or PET/CT for patients with metal implants).
Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis	11 Participants

Adverse Events

18F-FSPG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Phone: (650) 725-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place