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Non-Invasive Characterization in Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02017522
Recruitment Status : Terminated (Poor initial results. Scans were of insufficient quality for study purpose.)
First Posted : December 20, 2013
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Venkatesh L. Murthy, M.D., Ph.D., University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cardiac Sarcoidosis
Intervention Device: 11C-PBR PET
Enrollment 3
Recruitment Details  
Pre-assignment Details Five potential participants signed consents, but only three passed screening.
Arm/Group Title 11C-PBR PET
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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.

Period Title: Overall Study
Started 3
Scan 2
Completed 2
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title 11C-PBR PET
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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.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  66.7%
>=65 years
1
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title Ratio of 11C-PBR28 in the Myocardium
Hide Description 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.
Time Frame 1 hour scan
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Hide Analysis Population Description
Insufficient myocardial tissue contrast to define abnormal and normal regions.
Arm/Group Title 11C-PBR PET
Hide Arm/Group Description:

Characters remaining: 623 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis
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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.

Time Frame 1 hour scan
Hide Outcome Measure Data
Hide Analysis Population Description
Because the two scans performed provided inadequate clarity to allow any analysis, the additional measurements anticipated as secondary were not feasible.
Arm/Group Title 11C-PBR PET
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame about 2 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 11C-PBR PET
Hide Arm/Group Description

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 being evaluated.

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 that their treating doctor ordered. 11C-PBR28 will be used as the radiotracer. On either the same day or a different day, a cardiac MRI will be performed.

All-Cause Mortality
11C-PBR PET
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
11C-PBR PET
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
11C-PBR PET
Affected / at Risk (%)
Total   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Venkatesh Murthy, MD
Organization: University of Michigan
Responsible Party: Venkatesh L. Murthy, M.D., Ph.D., University of Michigan
ClinicalTrials.gov Identifier: NCT02017522     History of Changes
Other Study ID Numbers: HUM00079881
First Submitted: December 16, 2013
First Posted: December 20, 2013
Results First Submitted: July 3, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018