Trial Outcomes & Findings for Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening (NCT NCT04877912)
NCT ID: NCT04877912
Last Updated: 2026-03-20
Results Overview
The number of abbreviated scans that successfully determines a cancer, confirmed by biopsy, based on the radiologist determination that the MRI findings are suspicious. Suspicious lesions were assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0 (incomplete - need additional imaging evaluation), 4 (suspicious for malignancy - biopsy should be considered) and 5 (highly suggestive of malignancy - appropriate action should be taken).
TERMINATED
166 participants
30 days
2026-03-20
Participant Flow
Recruitment has been completed.
Participant milestones
| Measure |
MRI Unknown Cancer Status Group
Women with dense breasts and/or women who have intermediate risk of breast cancer for this study. Subjects will receive an MRI exam that is research-only.
Abbreviated MRI Scan: All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better.
The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible.
|
|---|---|
|
Overall Study
STARTED
|
166
|
|
Overall Study
COMPLETED
|
166
|
|
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 |
MRI Unknown Cancer Status Group
n=166 Participants
Women with dense breasts and/or women who have intermediate risk of breast cancer for this study. Subjects will receive an MRI exam that is research-only.
Abbreviated MRI Scan: All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better.
The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=166 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
166 Participants
n=166 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=166 Participants
|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 13.5 • n=166 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=166 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=166 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=166 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe number of abbreviated scans that successfully determines a cancer, confirmed by biopsy, based on the radiologist determination that the MRI findings are suspicious. Suspicious lesions were assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0 (incomplete - need additional imaging evaluation), 4 (suspicious for malignancy - biopsy should be considered) and 5 (highly suggestive of malignancy - appropriate action should be taken).
Outcome measures
| Measure |
MRI Unknown Cancer Status Group
n=166 Participants
We will scan 150 women with dense breasts and/or women who have intermediate risk of breast cancer for this study. Subjects will receive an MRI exam that is research-only.
Abbreviated MRI Scan: All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better.
The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible.
|
|---|---|
|
True Positive
|
0.09 true positive scans
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: 30 daysThe abbreviated scan successfully determines no cancers are present, as confirmed with mammography or a standard MRI.
Outcome measures
Outcome data not reported
Adverse Events
MRI Unknown Cancer Status Group
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