Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.
PROSPECTS
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.
1 other identifier
interventional
100,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2018
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedStudy Start
First participant enrolled
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedNovember 6, 2019
November 1, 2019
5.5 years
October 10, 2017
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the cost effectiveness of breast cancer screening with digital breast tomosynthesis and 2DDM vs standard screening with 2DDM
To compare the effectiveness of breast cancer screening with DBT and 2D mammography with standard 2D mammography screening by measuring the internal cancer rate in women undergoing DBT and 2D mammography VS the interval cancer rate in women undergoing standard 2D mammography. (Estimated interval cancer rates - intervention group 1.85/1000 screened; control group 2.85/1000 screened)
outcome measures to be reported from 2-7 years following beginning of recruitment into the trial
Study Arms (2)
digital breast tomosynthesis
EXPERIMENTALTomosynthesis and two dimension digital mammography
control
ACTIVE COMPARATORstandard two dimension digital mammography
Interventions
pseudo three dimension mammography
Eligibility Criteria
You may qualify if:
- women aged 50-70 years attending for routine breast cancer screening
You may not qualify if:
- women aged 47-49 and 71-73 invited to participate in the age extension trial
- women who are unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College Hospital NHS Foundation Trust
London, United Kingdom
Related Publications (2)
J 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: 38852330DERIVEDPartridge 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: 37589906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Michell, FRCR
King's College Hospital NHS Foundation Trust, London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- participants blinded to type of screening scan
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
November 7, 2018
Study Start
December 17, 2018
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
November 6, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make individual participant data available to individuals outside the research team