Breast CancerREAD RISKNCT05268913
Towards Early Detection of Breast Cancer in High Risk Population
An observational study of Breast Cancer, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI scan and Blood test
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2022to 14 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- -
- 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)
Show all 21Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Biomedical Imaging Centre
Aberdeen, Aberdeenshire, AB25 2ZD
About this study
Official title: 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. 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.
- Conditions
- Breast Cancer
- Being tested
- MRI scan, Blood test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
Participants will undertake a magnetic resonance imaging scan.
Blood testBiological
Participants will undertake a fasting blood test.
| Study group | Role | What they receive |
|---|---|---|
| Women with BRCA1/2 genes | Not described Receives: Diagnostic Test: MRI scan; Biological: Blood test | |
| Women with breast cancer | Not described Receives: Diagnostic Test: MRI scan; Biological: Blood test | |
| Women with obesity | Not described Receives: Diagnostic Test: MRI scan; Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start28 Nov 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268913
- Sponsor's protocol ID
- 2-102-21
- Acronym
- READ RISK
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods
- ClinicalTrials.gov ID
- NCT05268913
- Acronym / sponsor ID
- READ RISK / 2-102-21
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (21 listed)
- -
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanParticipants will undertake a magnetic resonance imaging scan. | Diagnostic test | Women with BRCA1/2 genes, Women with breast cancer, Women with obesity |
| Blood testParticipants will undertake a fasting blood test. | Biological | Women with BRCA1/2 genes, Women with breast cancer, Women with obesity |
Primary outcome
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: %.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of lipid composition in the breast (time frame: One hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.