Trial Outcomes & Findings for Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia (NCT NCT03505372)
NCT ID: NCT03505372
Last Updated: 2020-02-11
Results Overview
Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
TERMINATED
NA
5 participants
3 months
2020-02-11
Participant Flow
5 patients were recruited
Participant milestones
| Measure |
Contrast Enhanced Mammography
* The CESM images will be performed according to clinical protocol
* Images will be acquired within approximately 2-12 minutes of contrast injection
* A total of four images per breast will be acquired with low and high energy
* Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
* The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
* The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement
Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
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 |
Contrast Enhanced Mammography
n=5 Participants
* The CESM images will be performed according to clinical protocol
* Images will be acquired within approximately 2-12 minutes of contrast injection
* A total of four images per breast will be acquired with low and high energy
* Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
* The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
* The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement
Contrast enhanced mammography: Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Images were performed but outcome data was not collected and therefore we cannot provide any analysis.
Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Images were performed but outcome data was not collected and therefore we cannot provide any analysis.
Investigators will evaluate how incidental findings seen on CESM impact the surgical management of patients diagnosed with ADH. The initial surgical management documented in the clinical report (created before CESM performed) will be compared with the surgical management documented in the medical record after the CESM was performed to determine the change.
Outcome measures
Outcome data not reported
Adverse Events
Contrast Enhanced Mammography
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Jordana Phillips
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place