Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?
NCT ID: NCT03949946
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2019-06-20
2021-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High-risk
Female participants confirmed to be BRCA1/2 or TP53 gene carriers
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.
Patients
Female participants confirmed to have invasive ductal carcinoma of the breast
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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NHS Grampian
OTHER_GOV
University of Aberdeen
OTHER
Responsible Party
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Principal Investigators
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Jiabao He, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Locations
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Aberdeen Biomedical Imaging Centre
Aberdeen, Aberdeenshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Gabriel Cheung, PhD
Role: primary
Other Identifiers
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2-025-19
Identifier Type: -
Identifier Source: org_study_id