Trial Outcomes & Findings for Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications (NCT NCT02062008)

NCT ID: NCT02062008

Last Updated: 2021-06-16

Results Overview

Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

2 hours

Results posted on

2021-06-16

Participant Flow

Participant milestones

Participant milestones
Measure
Cardiac Patients Receiving PET/MR
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cardiac Patients Receiving PET/MR
n=2 Participants
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
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
0 Participants
n=5 Participants
Age, Continuous
48 years
STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.

Outcome measures

Outcome measures
Measure
Cardiac Patients Receiving PET/MR
n=2 Participants
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.
2 quality image

Adverse Events

Cardiac Patients Receiving PET/MR

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

miguel hernandez pampaloni

University of California San Francisco

Phone: 4153531886

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place