Clinical trial · Interventional
Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.
Prospective Randomized Trial of Digital Breast Tomosynthesis (DBT) Plus Standard 2D Digital Mammography (2DDM) or Synthetic 2D Digital Mammography (S2D) Compared to Standard 2DDM in Breast Cancer Screening.
- 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 accuracy of standard two dimension digital mammography (2DDM) in breast cancer screening is limited because of superimposition of normal breast structures onto a two dimensional image. Mammography signs of breast cancer may be obscured, resulting in delay in the diagnosis of breast cancer. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to recall for further tests. Digital breast tomosynthesis (DBT) is a new x ray mammography technique which provides three dimensional information to the film reader, overcoming many of the interpretation problems due to tissue superimposition. Studies of DBT + 2DDM in screening have shown increased cancer detection rates and lower false positive recall rates. There may be increased costs related to the technology and reading times. The aim of this study is to measure the impact and cost effectiveness of DBT + 2DDM in routine screening compared to standard 2DDM.100,000 women wil be recruited using NHS BSP screening sites. At each site, through a clinic randomization process, half of the participants will undergo standard screening with 2DDM (the control group) and half will undergo screening using DBT+2DDM.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital breast tomosynthesis | Diagnostic Test | — | UNRESOLVED |
| standard two dimension digital mammogram | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- digital breast tomosynthesis
- description
- Tomosynthesis and two dimension digital mammography
- interventionNames
- Diagnostic Test: digital breast tomosynthesis
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- standard two dimension digital mammography
- interventionNames
- Diagnostic Test: standard two dimension digital mammogram
Primary outcomes (1)
- measure
- To compare the cost effectiveness of breast cancer screening with digital breast tomosynthesis and 2DDM vs standard screening with 2DDM
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * women aged 50-70 years attending for routine breast cancer screening Exclusion Criteria: * women aged 47-49 and 71-73 invited to participate in the age extension trial * women who are unable to give informed consent
References
Publications (2)
- DERIVEDJ W Partridge G, Darker I, J James J, Satchithananda K, Sharma N, Valencia A, Teh W, Khan H, Muscat E, J Michell M, Chen Y. How long does it take to read a mammogram? Investigating the reading time of digital breast tomosynthesis and digital mammography. Eur J Radiol. 2024 Aug;177:111535. doi: 10.1016/j.ejrad.2024.111535. Epub 2024 May 29. PMID 38852330
- DERIVEDPartridge GJW, Taib AG, Phillips P, James JJ, Satchithananda K, Sharma N, Morel J, McAvinchey R, Valencia A, Teh W, Khan H, Muscat E, Michell MJ, Chen Y. Take a break: should breaks be enforced during digital breast tomosynthesis reading sessions? Eur Radiol. 2024 Feb;34(2):1388-1398. doi: 10.1007/s00330-023-10086-4. Epub 2023 Aug 17. PMID 37589906