Clinical trial · Interventional
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
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
NCT02306265CI-TRIAL-00036790ADAPTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Screening | — | UNRESOLVED | — |
| Tumors, Breast | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DBT | Device | — | UNRESOLVED |
| FFDM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- DBT and FFDM
- description
- Subjects will undergo 2D breast imaging with full-field digital mammography (FFDM) device (active comparator) and 3D breast imaging with digital breast tomosynthesis (DBT) device (experimental).
- interventionNames
- Device: FFDM
- Device: DBT
Primary outcomes (1)
- measure
- Number of Participants With Imaging Data Collected
- timeFrame
- within 30 days of enrollment
- description
- Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.