Clinical trial · Interventional
Tomosynthesis Mammographic Imaging Screening Trial
Tomosynthesis Mammography Imaging Screening Trial Lead-in
NCT02616432CI-TRIAL-00089977TMISTLead-inactive not recruitingN/AClinicalTrials.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)
A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tomosynthesis + FFDM
- description
- Women enrolled to DBT Arm will undergo manufacturer-defined DBT
- interventionNames
- Device: Tomosynthesis
- type
- NO_INTERVENTION
- label
- FFDM - Standard of Care for Screening
- description
- Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired
Primary outcomes (1)
- measure
- Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
- timeFrame
- 3 year follow-up
- description
- To compare the diagnostic accuracy using the area under the curve (AUC) score generated by receiver operator characteristic (ROC) analysis of digital breast tomosynthesis plus full-field digital mammography (DBT) versus full-field digital mammography (FFDM) alone for breast cancer screening. The examinations will be interpreted by local Breast Imaging radiologists. Cancer status will be pathologically confirmed. The women would undergo three consecutive screening rounds in the assigned arm followed by one year of standard of care imaging follow-up.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic women age 40 and over * Scheduled for screening mammogram * Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol * Willing and able to provide a written informed consent. Exclusion Criteria: * Presenting for mammography with symptoms of breast disease * Have new breast complaints (e.g. lump, nipple discharge) * Have had a mammogram of both breasts within the last 11 months * Previous personal history of breast cancer * Has breast enhancements (e.g. implants or injections) * Pregnancy or intent to become pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.