Towards Early Detection of Breast Cancer in High Risk Population (READ RISK)

February 24, 2022 updated by: University of Aberdeen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
        • Aberdeen Biomedical Imaging Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with BRCA1/2 genes
Diagnostic test: MRI scan
Participants will undertake a magnetic resonance imaging scan.
Biological: Blood test
Participants will undertake a fasting blood test.
Women with breast cancer
Diagnostic test: MRI scan
Participants will undertake a magnetic resonance imaging scan.
Biological: Blood test
Participants will undertake a fasting blood test.
Women with obesity
Diagnostic test: MRI scan
Participants will undertake a magnetic resonance imaging scan.
Biological: Blood test
Participants will undertake a fasting blood test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of lipid composition in the breast
Time Frame: One hour

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
Time Frame: One hour

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
Time Frame: One hour

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
Time Frame: One hour

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-102-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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