Breast Screening - Risk Adaptive Imaging for Density

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography

NCT00450359

Breast Cancer

COMPLETED NA

Using AI to Select Women for Supplemental MRI in Breast Cancer Screening

NCT04832594

Breast Cancer

UNKNOWN NA

Efficacy of Tomosynthesis in the BIRADS 3 Population

NCT00763100

Breast Cancer

COMPLETED

Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images

NCT05960188

Breast Cancer Screening

COMPLETED NA

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

NCT01669148

Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.

Group Type NO_INTERVENTION

No interventions assigned to this group