Breast Cancer Clinical Trial
— ADAPTOfficial title:
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-SCR: Recruitment Plan for Asymptomatic Women Undergoing Screening Mammography
Verified date | January 2019 |
Source | GE Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
Status | Completed |
Enrollment | 250 |
Est. completion date | July 7, 2017 |
Est. primary completion date | July 7, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - Women aged 30 years or older (=30 years old); - Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days; - Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility; - Are able and willing to comply with study procedures; - Have signed and dated the informed consent form; - Are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one). Exclusion Criteria: - Have been previously included in this study; - Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included; - Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT examination; - Have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes; - Have breast implant(s); - Have reconstructed breast(s). |
Country | Name | City | State |
---|---|---|---|
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Beaumont Health System | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Device Malfunctions by Modality (DBT or FFDM). | Number of device malfunctions by modality (DBT or FFDM) | Duration of study -approximately 26 months | |
Other | Cancer-positive Participants | Participants confirmed to be positive for cancer on histology review. | Duration of study - approximately 26 months | |
Primary | Number of Participants With Imaging Data Collected | Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography. | within 30 days of enrollment |
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