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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949946
• Other study ID #: 2-025-19
• Status: Recruiting
• Start date: June 20, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: University of Aberdeen
• Contact: Gabriel Cheung, PhD
• Phone: (+44)1224 438351
• Email: g.cheung[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Aberdeen Biomedical Imaging Centre	Aberdeen	Aberdeenshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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