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

Is Lipid Composition Mapping Using Magnetic Resonance Imaging 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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Magnetic resonance imaging (MRI)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
      • Recruiting
      • Aberdeen Biomedical Imaging Centre
      • Contact: Gabriel Cheung, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female participants confirmed to be BRCA1/2 and TP53 gene carriers and females participants confirmed to have invasive ductal carcinoma of the breast.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-risk; Female participants confirmed to be BRCA1/2 or TP53 gene carriers	Procedure: Magnetic resonance imaging (MRI); 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.
Patients; Female participants confirmed to have invasive ductal carcinoma of the breast	Procedure: Magnetic resonance imaging (MRI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saturated fatty acids in breasts of patients and high-risk group	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 (%)	Baseline
Monounsaturated fatty acids in breasts of patients and high-risk group	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 (%)	Baseline
Polyunsaturated fatty acids in breasts of patients and high-risk group	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 (%)	Baseline

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: NHS Grampian
• Investigators: Principal Investigator: Jiabao He, PhD, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: MRI; lipid composition
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2-025-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No