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CompletedNCT05268913READ RISKUpdated Aug 31, 2026

Towards Early Detection of Breast Cancer in High Risk Population

An observational study in Breast Cancer, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of Aberdeen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 30 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 170 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testMRI scan

    Participants will undertake a magnetic resonance imaging scan.

  • BiologicalBlood test

    Participants will undertake a fasting blood test.

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What researchers measure

Primary outcomes

  1. 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: %.

    Time frame: One hour

  2. 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.

    Time frame: One hour

  3. 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.

    Time frame: One hour

  4. 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.

    Time frame: One hour

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Study locations

1 site
  • Aberdeen Biomedical Imaging Centre
    Aberdeen, Aberdeenshire AB25 2ZD, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05268913
Lead sponsor
University of Aberdeen
Responsible party
Sponsor
First posted
Mar 7, 2022
Start date
Nov 28, 2022
Primary completion
May 14, 2024
Completion
May 14, 2024
Last update
Aug 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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