Towards Early Detection of Breast Cancer in High Risk Population

NCT05268913 | Unknown

• 1 other identifier: 2-102-21
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Women with BRCA1/2 genes

Diagnostic Test: MRI scan; Biological: Blood test

Women with breast cancer

Diagnostic Test: MRI scan; Biological: Blood test

Women with obesity

Diagnostic Test: MRI scan; Biological: Blood test

Interventions

MRI scan DIAGNOSTIC_TEST

Participants will undertake a magnetic resonance imaging scan.

Women with BRCA1/2 genes; Women with breast cancer; Women with obesity

Blood test BIOLOGICAL

Participants will undertake a fasting blood test.

Women with BRCA1/2 genes; Women with breast cancer; Women with obesity

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with BRCA1/2 genes will be identified and approached by the geneticist and research nurse at the family high risk clinic. Patients will be identified and approached by the breast surgeon and breast care nurse at the results clinic. Women with obesity will be identified through organisation emails, word of month and leaflets in the community health clinic for residents of Aberdeenshire.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Aberdeen Biomedical Imaging Centre

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging; Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 7, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)