Trial Outcomes & Findings for Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study (NCT NCT03846947)

Last Updated: 2023-05-11

Results Overview

The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

during MRI, approximately 1 hour

Results posted on

2023-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Overall Study technical issues with imaging sequence	2

Baseline Characteristics

Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=28 Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Age, Continuous	46.98 years STANDARD_DEVIATION 13.33 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	28 participants n=93 Participants

PRIMARY outcome

Timeframe: during MRI, approximately 1 hour

Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence	1.07 ratio Standard Deviation 0.23

PRIMARY outcome

Timeframe: during MRI, approximately 1 hour

Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.

The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence	1.03 ratio Standard Deviation 0.24

PRIMARY outcome

Timeframe: during MRI, approximately 1 hour

Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.

The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time.

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants All participants will receive the investigational MR Fingerprinting sequence. MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence	1.08 ratio Standard Deviation 0.17

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

UNC Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place