Skip to content

Towards Early Detection of Breast Cancer in High Risk Population

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05268913
Acronym
READ RISK
Enrollment
30
Registered
2022-03-07
Start date
2022-11-28
Completion date
2024-05-14
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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. The investigators 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. The investigators 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.

Interventions

DIAGNOSTIC_TESTMRI scan

Participants will undertake a magnetic resonance imaging scan.

BIOLOGICALBlood test

Participants will undertake a fasting blood test.

Sponsors

University of Aberdeen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of lipid composition in the breastOne hourThe 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 breastOne hourSkewness 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 breastOne hourEntropy 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 breastOne hourKurtosis 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026