Trial Outcomes & Findings for Non-Invasive Characterization in Cardiac Sarcoidosis (NCT NCT02017522)

Results Overview

The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

1 hour scan

Results posted on

2018-08-01

Participant Flow

Five potential participants signed consents, but only three passed screening.

Participant milestones

Participant milestones
Measure	11C-PBR PET Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test from working. All participants who proceed will return on at least one additional day to undergo a positron emission tomography (PET) scan with 11C-PBR28 as the radiotracer to evaluate inflammation due to cardiac sarcoidosis.
Overall Study STARTED	3
Overall Study Scan	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	11C-PBR PET Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test from working. All participants who proceed will return on at least one additional day to undergo a positron emission tomography (PET) scan with 11C-PBR28 as the radiotracer to evaluate inflammation due to cardiac sarcoidosis.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Non-Invasive Characterization in Cardiac Sarcoidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	11C-PBR PET n=3 Participants Subjects will have a blood sample drawn to evaluate the presence of a specific genetic variation which would prevent the new type of imaging test we are evaluating from working and we will test the inflammatory cells in the blood for the same purpose. All participants who proceed will have to return on at least one additional day to undergo a positron emission tomography (PET) scan similar to the scan your doctor ordered with 11C-PBR28 as the radiotracer. On either the same day or a different day, participants will also undergo a cardiac MRI.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour scan

Population: Insufficient myocardial tissue contrast to define abnormal and normal regions.

The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour scan

Population: Because the two scans performed provided inadequate clarity to allow any analysis, the additional measurements anticipated as secondary were not feasible.

As a secondary outcome of this study we will evaluate the ratio of 11C-PBR28 PET activity in regions with fibrosis indicated by decreased myocardial perfusion on 82Rb PET and/or late gadolinium enhancement on cardiac MRI without imaging signs of active inflammation compared to 11C-PBR28 PET activity in myocardial segments which appear normal on 82Rb PET, FDG PET and cardiac MRI. This outcome will thus be expressed by 11C-PBR28 PET uptake in fibrotic regions as a percentage of uptake in normal segments We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens.

Outcome measures

Outcome data not reported

Adverse Events

11C-PBR PET

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

Venkatesh Murthy, MD

University of Michigan

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place