Towards Early Detection of Breast Cancer in High Risk Population

Breast Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05268913
• Other study ID #: 2-102-21
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2022
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• MRI scan
Participants will undertake a magnetic resonance imaging scan.

Biological:
• Blood test
Participants will undertake a fasting blood test.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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