Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis (AMELIA)
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|ClinicalTrials.gov Identifier: NCT03616457|
Recruitment Status : Withdrawn (Change in business need.)
First Posted : August 6, 2018
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Automated Breast Ultrasound (ABUS)|
Following consenting procedures, subjects will undergo standard of care DBT of both breasts or of one breast if they have had prior uni-lateral mastectomy. Subjects will also undergo ABUS of both breasts or of one breast if they have had prior uni-lateral mastectomy. These imaging exams will be done per the sites routine practice, and can be done in any order.
Images will be read and assessed by one (1) Mammography Quality Standards Act (MQSA)-qualified reader. The evaluating radiologist will use the image reconstruction views appropriate for the evaluation, per his or her medical judgment, and handle diagnostic evaluations in accordance with the standard of care at the investigational site. The DBT images will be read and assessed first and independent of ABUS images. DBT plus ABUS will then be read per routine practice and assessed. Images will not be read until both imaging exams have been completed.
If screening shows a suspicious finding, subjects will receive standard of care follow-up and appropriate workup, which may include biopsy (as needed), to determine cancer status. Subjects will be followed at approximately one year (11- to 16-months) unless negative histopathology with image concordance or positive cancer status is histologically determined prior to one-year follow-up. Follow up procedures will be conducted as per the sites standard of care.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Evaluation of Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis in Women With Dense Breasts (AMELIA)|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
All Study Participants
All study participants will undergo the same study procedures, including Automated Breast Ultrasound (ABUS).
Device: Automated Breast Ultrasound (ABUS)
Participants will undergo imaging with ABUS.
- Cancer Detection Rate [ Time Frame: up to 16 months ]Cancer detection rate of DBT plus ABUS and DBT alone
- Invasive Cancer Detection [ Time Frame: up to 16 months ]To demonstrate DBT plus ABUS has non-inferior invasive cancer detection relative to DBT alone in women with dense breasts
- Positive Predictive Value [ Time Frame: up to 16 months ]To demonstrate DBT plus ABUS has non-inferior positive predictive value (PPV 1) for breast cancer relative to DBT alone in women with dense breasts.
- Recall Rates [ Time Frame: up to 16 months ]To summarize recall rate of DBT plus ABUS in relation to the recall rate of DBT alone for breast cancer screening in dense breasts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616457
|Principal Investigator:||Georgia Spear||NorthShore University HealthSystem|