Automated Low Dose Risk Assessment Mammography (ALDRAM)

NCT05796219 | Completed

• 1 other identifier: B00394
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer (BC) is the commonest cause of death in young women. Breast screening in women aged 35-45, at increased risk due to their family history, has been shown to improve survival. However, 80% of women who develop BC do not have a family history. Numerous studies have shown that high mammographic density (MD) is one of the strongest risk factors for BC development. Full field digital mammography (FFDM) can be used to assess MD, however it is not recommended for population BC screening in those \<40 years of age due to the concerns about the use of ionising radiation. Safe and accurate high throughput methods to quantify MD in young women are thus required to improve risk prediction and reduce BC mortality. This study aims to develop a low dose mammogram, with quantification of density using artificial intelligence, to facilitate high throughput risk assessment in young women. 600 women aged 30-45, previously identified as being at increased risk of BC and attending for annual mammography at The Nightingale Centre will be recruited. Participants will undergo FFDM of the right breast as usual, however, following acquisition of the craniocaudal (CC) view, the breast will remain compressed and the mammogram dose reduced by 90% to deliver a LD mammogram. This process will be repeated for the right medio-lateral oblique (MLO) view. The left breast FFDM will proceed as normal. It is estimated that each extra exposure will take 1-2 minutes only. Deep machine learning methods will be used to define the relationship between standard FFDM views and their low dose counterparts and determine which view (CC vs MLO) provides the best correlation to be taken forward to the next stage of the research.

Conditions

Breast Cancer

Keywords

Low dose mammogram

Outcome Measures

Primary Outcomes (1)

• Correlation between full dose and low dose percent mammographic density estimates

  Full dose and Low dose mammograms will be analysed using an established AI technique, the predicted Visual Analogue Score (pVAS), to determine the percent mammographic density (%MD). Correlation between the full and low dose image derived %MD across the whole study population will be assessed using Pearson correlation coefficient.

  The low dose mammogram will be taken immediately after the full dose exposure, under the same breast compression.

Study Arms (1)

Low dose mammogram

OTHER

Low dose mammo to compare with standard mammo

Radiation: Low dose mammogram

Interventions

Low dose mammogram RADIATION

Low dose mammogram

Low dose mammogram

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: Females with moderate to high risk of breast cancer, identified through and attending for annual review and mammography at the family history clinic, Nightingale Centre, Manchester * Current age 30-45 years * Capable of providing informed consent to a patient information sheet written in English
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females with moderate to high risk of breast cancer, identified through and attending for annual review and mammography at the family history clinic, Nightingale Centre, Manchester
• Current age 30-45 years
• Capable of providing informed consent to a patient information sheet written in English

You may not qualify if:

• Prior breast cancer
• Prior breast augmentation or reduction
• Participation in the TARA-Prev study which included an additional mammogram and thus radiation dose

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

The Nightingale Centre

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The research question for this study is whether an automated, low dose mammogram can be developed to provide an accurate assessment of mammographic density, and thus breast cancer risk, in women aged 30-45.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 3, 2023
• Study Start: February 22, 2019
• Primary Completion: May 5, 2020
• Study Completion: February 16, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

GB (1)