Clinical trial NCT03949946: Is Lipid Mapping an Effective Early Detection Tool for Breast Cancer in High-risk Populations?
Official title: Is Lipid Composition Mapping Using Magnetic Resonance Imaging an Effective Early Detection Tool for Breast Cancer in High Risk Populations?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: lipid composition
MRI
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2019-05-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Saturated fatty acids in breasts of patients and high-risk group
timeFrame: Baseline
measure: Monounsaturated fatty acids in breasts of patients and high-risk group
timeFrame: Baseline
measure: Polyunsaturated fatty acids in breasts of patients and high-risk group
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Biomedical Imaging Centre
state: Aberdeenshire
Study officials:
affiliation: University of Aberdeen
name: Jiabao He, PhD
role: PRINCIPAL_INVESTIGATOR
References: