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?
1 other identifier
observational
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 18, 2020
November 1, 2020
2.4 years
May 9, 2019
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (%)
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 (%)
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 (%)
Baseline
Study Arms (2)
High-risk
Female participants confirmed to be BRCA1/2 or TP53 gene carriers
Patients
Female participants confirmed to have invasive ductal carcinoma of the breast
Interventions
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
Female participants confirmed to be BRCA1/2 and TP53 gene carriers and females participants confirmed to have invasive ductal carcinoma of the breast.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- NHS Grampiancollaborator
Study Sites (1)
Aberdeen Biomedical Imaging Centre
Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiabao He, PhD
University of Aberdeen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 14, 2019
Study Start
June 20, 2019
Primary Completion
November 30, 2021
Study Completion
December 31, 2021
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share