Towards Early Detection of Breast Cancer in High Risk Population

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: MRI scan; Biological: Blood test

• Registration Number: NCT05268913
• Lead Sponsor: University of Aberdeen

Brief Summary

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. We 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.

We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study Start: 2022-03-01
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with obesity	MRI scan	-
Women with obesity	Blood test	-
Women with BRCA1/2 genes	Blood test	-
Women with BRCA1/2 genes	MRI scan	-
Women with breast cancer	MRI scan	-
Women with breast cancer	Blood test	-

Primary Outcome Measures

Name	Time	Method
Amount of lipid composition in the breast	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: %.
Spatial distribution (skewness) of lipid composition in the breast	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.
Spatial distribution (entropy) of lipid composition in the breast	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.
Spatial distribution (kurtosis) of lipid composition in the breast	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.

Trial Locations

Locations (1)

Aberdeen Biomedical Imaging Centre; 🇬🇧 Aberdeen, Aberdeenshire, United Kingdom