Towards Early Detection of Breast Cancer in High Risk Population

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: MRI scan
* Biological: Blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with BRCA1/2 genes<br> | Diagnostic Test: MRI scan<br>* Participants will undertake a magnetic resonance imaging scan.<br>Biological: Blood test<br>* Participants will undertake a fasting blood test.<br>|
| Women with breast cancer<br> | Diagnostic Test: MRI scan<br>* Participants will undertake a magnetic resonance imaging scan.<br>Biological: Blood test<br>* Participants will undertake a fasting blood test.<br>|
| Women with obesity<br> | Diagnostic Test: MRI scan<br>* Participants will undertake a magnetic resonance imaging scan.<br>Biological: Blood test<br>* Participants will undertake a fasting blood test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of lipid composition in the breast | 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: %. | One hour | 
| Spatial distribution (skewness) of lipid composition in the breast | 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. | One hour | 
| Spatial distribution (entropy) of lipid composition in the breast | 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. | One hour | 
| Spatial distribution (kurtosis) of lipid composition in the breast | 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. | One hour |