Trial Outcomes & Findings for Novel MRI Sequence- MR Fingerprinting (NCT NCT03722459)

NCT ID: NCT03722459

Last Updated: 2022-12-20

Results Overview

MR fingerprinting sequences will be examined to determine their utility for visualizing pathology.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Immediately following MRI completion, within approximately 5 minutes

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants will receive the investigational Magnetic Resonance (MR) Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel MRI Sequence- MR Fingerprinting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=22 Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	56.7 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 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	1 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following MRI completion, within approximately 5 minutes

Population: This study was to determine the number of participants with visualized pathology with the sequences. Due to technical issues the investigational sequence was unable to be used to visualize pathology for any of the participants.

MR fingerprinting sequences will be examined to determine their utility for visualizing pathology.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

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

Director, Clinical Research, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place