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Completed

NCT Number: NCT03949946

Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?

This study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. It is hypothesised that there is a significant difference in the extent of spatial variation in lipid composition in breast from MRI between genetic mutation carriers and patients with breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Aberdeen Biomedical Imaging Centre

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

About this study

Breast cancer is a major and expanding societal challenge despite the significant improvement in survival rate. The current screening method has been shown to lead to overtreatment, prompting the development of accurate early detection approaches targeting underlying clinical features. Patients with BRCA1/2 and TP53 genes are at risk of breast cancer and receive annual surveillance. However, the current diagnostic approach relies on detecting the changes to the growth of tumour only once cancer is well under development. Detecting earlier changes to breast fatty tissue may detect patients earlier and more accurately.

Breast fatty tissue is composed of different fatty acids and a difference in the fatty acid composition has been shown in BRCA1/2 gene carriers. Measurement of lipid composition can be achieved using a specialist magnetic resonance spectroscopy method, but is limited to sampling a small area and is unable to provide the full picture of lipid composition distribution during early cancer growth. Recently, magnetic resonance chemical shift imaging, through combining magnetic resonance spectroscopy and imaging approaches, has been developed to provide lipid composition maps of the entire breast.

The investigators propose to perform lipid mapping in the breasts of 20 genetic mutation carriers at high risk of breast cancer and 20 patients with newly diagnosed breast cancer to examine the sensitivity of the method. The overarching aim is to improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer through the assessment of whole breast lipid composition.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female over 18 years old
  • BRCA1/2 or TP53 gene carriers (high-risk group)
  • invasive ductal carcinoma of the breast (patient group)
  • not having any metabolic disorders (e.g., diabetes)
  • not on any long term medications that may affect lipid metabolism (e.g., statins)

Exclusion criteria

  • female under 18 years old
  • male
  • affected by metabolic disorders (e.g., diabetes)
  • on long term medications that affect lipid metabolism (e.g., statins)
  • contraindicated for MR investigations (poor renal function and metal implants)
  • concurrent cancer in other sites
  • concurrent hormone treatment, chemotherapy or underwent surgery
  • non-English speakers

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

MRI scan uses radio waves in a magnetic field to obtain images of the breast. It is non-invasive and participants will not be exposed to harmful radiation. An image contrast agent will be used to enhance image clarity. Participants will be scanned lying face-down on a specially-designed bed and ear protectors will be provided to screen out background noise.

Primary outcomes

  1. Saturated fatty acids in breasts of patients and high-risk group

    Time frame: Baseline

    Saturated fatty acids (SFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group

    SFA will be measured in percentage (%)

  2. Monounsaturated fatty acids in breasts of patients and high-risk group

    Time frame: Baseline

    Monounsaturated fatty acids (MUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group

    MUFA will be measured in percentage (%)

  3. Polyunsaturated fatty acids in breasts of patients and high-risk group

    Time frame: Baseline

    Polyunsaturated fatty acids (PUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group

    PUFA will be measured in percentage (%)

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Official study title

Is Lipid Composition Mapping Using Magnetic Resonance Imaging an Effective Early Detection Tool for Breast Cancer in High Risk Populations?

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 14, 2019
Registry last updated
Aug 27, 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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