Clinical trial · Interventional
Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT
Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")
NCT02643966CI-TRIAL-00067663DBTUSTcompletedN/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 purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.
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 |
|---|---|---|---|
| Whole breast ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole breast ultrasound
- description
- All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists
- interventionNames
- Device: Whole breast ultrasound
Primary outcomes (3)
- measure
- Cancer Yield Per 1,000
- timeFrame
- 3 Years
- description
- Results from the first radiologist observer are presented
- measure
- Sensitivity (True Positive Rate)
- timeFrame
- 3 years
- description
- DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 40 to 75 years of age with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis. Exclusion Criteria: * Known to be at high risk for breast cancer due to known or suspected pathologic BRCA mutation (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30; * No mammogram within the prior 3 years; * Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple; * Pregnancy or lactation within the prior 6 months; * Plan to become pregnant in the next two years, as mammography is not typically performed for screening pregnant women; * Breast implants, as assessment of breast density may be problematic; * Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months; * Prior or current malignancy other than the following: a) Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or b) Basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years. * Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years, to avoid contamination of results; * Unwilling or unable to provide consent.
References
Publications (1)
- DERIVEDBerg WA, Zuley ML, Chang TS, Gizienski TA, Chough DM, Bohm-Velez M, Sharek DE, Straka MR, Hakim CM, Hartman JY, Harnist KS, Tyma CS, Kelly AE, Waheed U, Houshmand G, Nair BE, Shinde DD, Lu AH, Bandos AI, Berg JM, Lettiere NB, Ganott MA. Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST). J Clin Oncol. 2023 May 1;41(13):2403-2415. doi: 10.1200/JCO.22.01445. Epub 2023 Jan 10. PMID 36626696