Breast Cancer Clinical Trial
— ALDRAMOfficial title:
Technical Development of Automated Low Dose Risk Assessment Mammography (ALDRAM) in Women Attending for Annual Mammography Through a Family History Clinic
Verified date | March 2023 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | February 16, 2023 |
Est. primary completion date | May 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Prior breast cancer - Prior breast augmentation or reduction - Participation in the TARA-Prev study which included an additional mammogram and thus radiation dose |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Nightingale Centre | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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