Trial Outcomes & Findings for iNOS With Positron Emission Tomography (PET) in Cellular Inflammation. (NCT NCT01066637)
NCT ID: NCT01066637
Last Updated: 2020-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
26 participants
Primary outcome timeframe
24-72 hours post [18F](+/-)NOS injection
Results posted on
2020-08-07
Participant Flow
Participant milestones
| Measure |
Dosimetry Group
To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (9 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.
\[18F\](+/-)NOS: Injection of radiotracer \[18F\](+/-)NOS for PET imaging and kinetic data analysis
|
Kinetic Analysis Group
Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.
\[18F\](+/-)NOS: Injection of radiotracer \[18F\](+/-)NOS for PET imaging and kinetic data analysis
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
10
|
|
Overall Study
COMPLETED
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dosimetry Group-measuring Radioisotope in Blood
n=16 Participants
To determine its potential for use in humans, we measured the level of 18F-NOS radiopharmaceutical in patients after orthotopic heart transplantation (OHT) (3 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.
The level of 18-F-NOS was measured at different time points in minutes after injection of the radioisotope: The measurement time points were 0/120 minutes, 30/150 minutes, 60/180 minutes, and 90/210 minutes. The imaging began from mid thigh, to the base of the brain.
|
Kinetic Analysis Group-measuring Levels of Nitric Oxide
n=10 Participants
Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
10 Participants
n=10 Participants
|
26 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
5 Participants
n=10 Participants
|
16 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 Participants
n=16 Participants
|
10 Participants
n=10 Participants
|
26 Participants
n=26 Participants
|
|
Dosimetry and Kinetics
|
—
|
—
|
0 Participants
The PI has left the institution and we no longer have access to this data.
|
PRIMARY outcome
Timeframe: 24-72 hours post [18F](+/-)NOS injectionPopulation: The PI has left the institution and all efforts to locate data have been exhausted. There is no access to study data and it therefore cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24-72 hours post [18F](+/-)NOS injectionPopulation: The PI has left the institution and all efforts to locate data have been exhausted. There is no access to study data and it therefore cannot be reported.
All subjects will receive a single intravenous administration of 7 mCi of \[18F\](+/-)NOS followed by dynamic PET/CT imaging
Outcome measures
Outcome data not reported
Adverse Events
Dosimetry Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Kinetic Analysis Group
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
Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Washington University School of Medicine
Phone: 314-747-3877
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place