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NCT Number: NCT05268913

Towards Early Detection of Breast Cancer in High Risk Population

Breast cancer is a major and growing health challenge, and the leading cause of cancer in women. As population obesity rates increase, the number of new breast cancer diagnosis continues to rise. Despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. Although underlying susceptibility caused by mutation in the genes including BRCA1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates.

Alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. The investigators have developed and tested a novel method to allow a standard 3T MRI scanner to perform quantitative 3D mapping of specific lipid molecules in the breast.

The investigators will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Aberdeen Biomedical Imaging Centre

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Women with BRCA1/2 genes:

  • female 18-55 years old, premenopausal
  • BRCA 1/2 gene carriers
  • not having any metabolic disorders (e.g., diabetes)
  • not on any long term medications that may affect lipid metabolism (e.g., statins)
  • BMI < 30

Women with breast cancer (no obesity):

  • females 18-55 years old, premenopausal
  • confirmed diagnosis of invasive ductal carcinoma of the breast
  • not having any metabolic disorders (e.g., diabetes)
  • not on any long term medications that may affect lipid metabolism (e.g., statins)
  • BMI < 30

Women with breast cancer (obesity):

  • BMI > 30
  • otherwise as women with breast cancer

Women with obesity:

  • females 18-55 years old, premenopausal
  • not having any metabolic disorders (e.g., diabetes)
  • not on any long term medications that may affect lipid metabolism (e.g., statins)
  • BMI > 30

Exclusion criteria

  • females under 18 or over 55 years old, postmenopausal
  • males
  • have metabolic disorders (e.g., diabetes)
  • on long term medications that may affect lipid metabolism (e.g., statins)
  • contraindicated for MR investigation (poor renal function and metal implants)
  • (for patients) concurrent cancer in other sites
  • (for patients) started hormone treatment, chemotherapy or breast surgery
  • non-English speakers

Treatment and study plan

MRI scan

Diagnostic Test

Participants will undertake a magnetic resonance imaging scan.

blood test

Biological

Participants will undertake a fasting blood test.

Primary outcomes

  1. Amount of lipid composition in the breast

    Time frame: One hour

    The percentage of monounsaturated fatty acids, polyunsaturated fatty acids and saturated fatty acids relative to total lipid will be measured using magnetic resonance imaging (MRI) scanner software and MATLAB computer programme.

    Unit of Measurement: %.

  2. Spatial distribution (skewness) of lipid composition in the breast

    Time frame: One hour

    Skewness measures the asymmetry in distribution. The skewness of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme.

    Unit of Measurement: unitless.

  3. Spatial distribution (entropy) of lipid composition in the breast

    Time frame: One hour

    Entropy measures the randomness in distribution. The entropy of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme.

    Unit of Measurement: unitless.

  4. Spatial distribution (kurtosis) of lipid composition in the breast

    Time frame: One hour

    Kurtosis measures the peakedness in distribution. The kurtosis of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme.

    Unit of Measurement: unitless.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods

Acronym: READ RISK

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2022
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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