- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949946
Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?
Is Lipid Composition Mapping Using Magnetic Resonance Imaging an Effective Early Detection Tool for Breast Cancer in High Risk Populations?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aberdeenshire
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Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
- Aberdeen Biomedical Imaging Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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High-risk
Female participants confirmed to be BRCA1/2 or TP53 gene carriers
|
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.
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Patients
Female participants confirmed to have invasive ductal carcinoma of the breast
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Saturated fatty acids in breasts of patients and high-risk group
Time Frame: Baseline
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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 (%) |
Baseline
|
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Monounsaturated fatty acids in breasts of patients and high-risk group
Time Frame: Baseline
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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 (%) |
Baseline
|
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Polyunsaturated fatty acids in breasts of patients and high-risk group
Time Frame: Baseline
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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 (%) |
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jiabao He, PhD, University of Aberdeen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-025-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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