Towards Early Detection of Breast Cancer in High Risk Population

NCT ID: NCT05268913

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with BRCA1/2 genes

MRI scan

Intervention Type: DIAGNOSTIC_TEST

Participants will undertake a magnetic resonance imaging scan.

Blood test

Intervention Type: BIOLOGICAL

Participants will undertake a fasting blood test.

Women with breast cancer

MRI scan

Intervention Type: DIAGNOSTIC_TEST

Participants will undertake a magnetic resonance imaging scan.

Blood test

Intervention Type: BIOLOGICAL

Participants will undertake a fasting blood test.

Women with obesity

MRI scan

Intervention Type: DIAGNOSTIC_TEST

Participants will undertake a magnetic resonance imaging scan.

Blood test

Intervention Type: BIOLOGICAL

Participants will undertake a fasting blood test.

Interventions

MRI scan

Participants will undertake a magnetic resonance imaging scan.

Intervention Type: DIAGNOSTIC_TEST

Blood test

Participants will undertake a fasting blood test.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aberdeen Biomedical Imaging Centre

Aberdeen, Aberdeenshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2-102-21

Identifier Type: -

Identifier Source: org_study_id