Breast CancerNCT03949946
Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?
An observational study of Breast Cancer, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2019to 28 Nov 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female participants confirmed to be BRCA1/2 and TP53 gene carriers and females participants confirmed to have invasive ductal carcinoma of the breast.
Who may be able to join
- female over 18 years old
- BRCA1/2 or TP53 gene carriers (high-risk group)
- invasive ductal carcinoma of the breast (patient group)
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
Who cannot join
- female under 18 years old
- male
- affected by metabolic disorders (e.g., diabetes)
- on long term medications that affect lipid metabolism (e.g., statins)
- contraindicated for MR investigations (poor renal function and metal implants)
- concurrent cancer in other sites
- concurrent hormone treatment, chemotherapy or underwent 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: Is Lipid Composition Mapping Using Magnetic Resonance Imaging an Effective Early Detection Tool for Breast Cancer in High Risk Populations?
This study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. It is hypothesised that there is a significant difference in the extent of spatial variation in lipid composition in breast from MRI between genetic mutation carriers and patients with breast cancer.
Read the detailed description
Breast cancer is a major and expanding societal challenge despite the significant improvement in survival rate. The current screening method has been shown to lead to overtreatment, prompting the development of accurate early detection approaches targeting underlying clinical features. Patients with BRCA1/2 and TP53 genes are at risk of breast cancer and receive annual surveillance. However, the current diagnostic approach relies on detecting the changes to the growth of tumour only once cancer is well under development. Detecting earlier changes to breast fatty tissue may detect patients earlier and more accurately.
Breast fatty tissue is composed of different fatty acids and a difference in the fatty acid composition has been shown in BRCA1/2 gene carriers. Measurement of lipid composition can be achieved using a specialist magnetic resonance spectroscopy method, but is limited to sampling a small area and is unable to provide the full picture of lipid composition distribution during early cancer growth. Recently, magnetic resonance chemical shift imaging, through combining magnetic resonance spectroscopy and imaging approaches, has been developed to provide lipid composition maps of the entire breast.
The investigators propose to perform lipid mapping in the breasts of 20 genetic mutation carriers at high risk of breast cancer and 20 patients with newly diagnosed breast cancer to examine the sensitivity of the method. The overarching aim is to improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer through the assessment of whole breast lipid composition.
- Conditions
- Breast Cancer
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- lipid composition, MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Procedure or surgery
MRI scan uses radio waves in a magnetic field to obtain images of the breast. It is non-invasive and participants will not be exposed to harmful radiation. An image contrast agent will be used to enhance image clarity. Participants will be scanned lying face-down on a specially-designed bed and ear protectors will be provided to screen out background noise.
| Study group | Role | What they receive |
|---|---|---|
| High-risk | Female participants confirmed to be BRCA1/2 or TP53 gene carriers Receives: Procedure: Magnetic resonance imaging (MRI) | |
| Patients | Female participants confirmed to have invasive ductal carcinoma of the breast Receives: Procedure: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saturated fatty acids in breasts of patients and high-risk group
Saturated fatty acids (SFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group
SFA will be measured in percentage (%)
Measured: Baseline
Monounsaturated fatty acids in breasts of patients and high-risk group
Monounsaturated fatty acids (MUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group
MUFA will be measured in percentage (%)
Measured: Baseline
Polyunsaturated fatty acids in breasts of patients and high-risk group
Polyunsaturated fatty acids (PUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group
PUFA will be measured in percentage (%)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start20 Jun 2019
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Jiabao He, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949946
- Sponsor's protocol ID
- 2-025-19
- Status last verified
- Aug 2026
- First submitted
- 9 May 2019
- Last updated
- 27 Aug 2026
- Results posted
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Lipid Composition Mapping Using Magnetic Resonance Imaging an Effective Early Detection Tool for Breast Cancer in High Risk Populations?
- ClinicalTrials.gov ID
- NCT03949946
- Acronym / sponsor ID
- 2-025-19
- Conditions
- Breast Cancer
- Keywords
- lipid composition, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 14 May 2019 (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.
This study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. It is hypothesised that there is a significant difference in the extent of spatial variation in lipid composition in breast from MRI between genetic mutation carriers and patients with breast cancer.
Detailed description
Breast cancer is a major and expanding societal challenge despite the significant improvement in survival rate. The current screening method has been shown to lead to overtreatment, prompting the development of accurate early detection approaches targeting underlying clinical features. Patients with BRCA1/2 and TP53 genes are at risk of breast cancer and receive annual surveillance. However, the current diagnostic approach relies on detecting the changes to the growth of tumour only once cancer is well under development. Detecting earlier changes to breast fatty tissue may detect patients earlier and more accurately.
Breast fatty tissue is composed of different fatty acids and a difference in the fatty acid composition has been shown in BRCA1/2 gene carriers. Measurement of lipid composition can be achieved using a specialist magnetic resonance spectroscopy method, but is limited to sampling a small area and is unable to provide the full picture of lipid composition distribution during early cancer growth. Recently, magnetic resonance chemical shift imaging, through combining magnetic resonance spectroscopy and imaging approaches, has been developed to provide lipid composition maps of the entire breast.
The investigators propose to perform lipid mapping in the breasts of 20 genetic mutation carriers at high risk of breast cancer and 20 patients with newly diagnosed breast cancer to examine the sensitivity of the method. The overarching aim is to improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer through the assessment of whole breast lipid composition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk | – | Procedure: Magnetic resonance imaging (MRI)Female participants confirmed to be BRCA1/2 or TP53 gene carriers |
| Patients | – | Procedure: Magnetic resonance imaging (MRI)Female participants confirmed to have invasive ductal carcinoma of the breast |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female participants confirmed to be BRCA1/2 and TP53 gene carriers and females participants confirmed to have invasive ductal carcinoma of the breast.
Key inclusion criteria (5 listed)
- female over 18 years old
- BRCA1/2 or TP53 gene carriers (high-risk group)
- invasive ductal carcinoma of the breast (patient group)
- 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)
- female under 18 years old
- male
- affected by metabolic disorders (e.g., diabetes)
- on long term medications that affect lipid metabolism (e.g., statins)
- contraindicated for MR investigations (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 |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI scan uses radio waves in a magnetic field to obtain images of the breast. It is non-invasive and participants will not be exposed to harmful radiation. An image contrast agent will be used to enhance image clarity. Participants will be scanned lying face-down on a specially-designed bed and ear protectors will be provided to screen out background noise. | Procedure or surgery | High-risk, Patients |
Primary outcome
Saturated fatty acids in breasts of patients and high-risk group
Time frame: Baseline
Saturated fatty acids (SFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group SFA will be measured in percentage (%)
Monounsaturated fatty acids in breasts of patients and high-risk group
Time frame: Baseline
Monounsaturated fatty acids (MUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group MUFA will be measured in percentage (%)
Polyunsaturated fatty acids in breasts of patients and high-risk group
Time frame: Baseline
Polyunsaturated fatty acids (PUFA) from tumour border and fatty tissue in patients and fibroglandular and fatty tissue in high-risk group PUFA will be measured in percentage (%)
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 27 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.
Jiabao He, PhD principal investigator
University of Aberdeen
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 5 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 27 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?
Saturated fatty acids in breasts of patients and high-risk group (time frame: Baseline). The study lists 3 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 27 Aug 2026.