Trial Outcomes & Findings for Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening (NCT NCT03495115)
NCT ID: NCT03495115
Last Updated: 2026-04-17
Results Overview
Comparison of participants with cancer in the DCE- MRI group compared to RSI group. Review of the examinations was performed by 3 expert breast imagers and number of cancers detected in each group were compared.
COMPLETED
NA
460 participants
2 years
2026-04-17
Participant Flow
Group1- Conventional Breast MRI Group 2 - Restriction spectrum imaging
Total 460 patients in each arm - 420 subjects were in screening population for high risk screening forming group 1 and 40 patients with BIRADS 4/5 getting a breast MRI prior to biopsy forming group 2. Both groups together were used for each arm which had the same population of 460 patients.
Participant milestones
| Measure |
Screening Breast MRI Versus Restriction Spectrum Imaging
Patients presenting for breast MRI. Study includes screening population (420 MRI) and diagnostic MRI, BIRADS 4/5 patients prior to biopsy as the reason for breast MRI (40 MRI) to enrich the cancer population in the cohort making a total of 460 patients.
These 460 patients first underwent conventional breast MRI and then underwent restriction spectrum imaging. The same 460 patients were part of both arms. We analyzed cancer detection rate with conventional breast MRI alone and compared it with cancer detection rate with restriction spectrum imaging alone.
|
|---|---|
|
Overall Study
STARTED
|
460
|
|
Overall Study
COMPLETED
|
460
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Screening Breast MRI Versus Restriction Spectrum Imaging
n=460 Participants
420 patients who underwent screening MRI and 40 patients with BIRADS 4/5 based on the mammogram patients prior to biopsy as the reason for breast MRI to enrich the cancer population in the cohort making a total of 460 patients.
These 460 patients first underwent conventional breast MRI and then underwent restriction spectrum imaging. The same 460 patients were part of both arms. We analyzed cancer detection rate with conventional breast MRI alone and compared it with cancer detection rate with restriction spectrum imaging alone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=460 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
400 Participants
n=460 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=460 Participants
|
|
Sex/Gender, Customized
SEX · FEMALE
|
460 Participants
n=460 Participants
|
|
Sex/Gender, Customized
SEX · MALE
|
0 Participants
n=460 Participants
|
|
Region of Enrollment
United States
|
460 Participants
n=460 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Review of the examinations by 3 expert breast imagers showed that there was no evidence for cancer with RSI in the patients who had cancer.
Comparison of participants with cancer in the DCE- MRI group compared to RSI group. Review of the examinations was performed by 3 expert breast imagers and number of cancers detected in each group were compared.
Outcome measures
| Measure |
DCE MRI
n=460 Participants
Screening population for high risk screening
Standard MRI obtained.( Dynamic Contrast Enhanced-MRI with Diffusion Weighted Imagery sequence)
MRI: A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
|
Restriction Spectrum Imaging (RSI)
n=460 Participants
RSI is a Diffusion Weighted Imagery sequence with a built in distortion-correction technique that can be applied to any diffusion technique using echo planar imaging acquisition.
|
|---|---|---|
|
Diagnostic Accuracy of Restriction Spectrum Imaging (RSI) in Comparison to Conventional Breast MRI for Detection of Breast Cancer in the Screening Population.
|
34 participants with identified cancer
|
0 participants with identified cancer
|
Adverse Events
Conventional Breast MRI
Restriction Spectrum Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place