MedTrace Logo

Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.

NCT03733106 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000

Last updated 2019-11-06

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

digital breast tomosynthesis

pseudo three dimension mammography

DIAGNOSTIC_TEST

standard two dimension digital mammogram

standard two dimension mammogram

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Michael J Michell, FRCR · King's College Hospital NHS Foundation Trust, London

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733106 on ClinicalTrials.gov