Clinical trial NCT05268913: Towards Early Detection of Breast Cancer in High Risk Population
Official title: Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with BRCA1/2 genes will be identified and approached by the geneticist and research nurse at the family high risk clinic. Patients will be identified and approached by the breast surgeon and breast care nurse at the results clinic. Women with obesity will be identified through organisation emails, word of month and leaflets in the community health clinic for residents of Aberdeenshire.

Brief summary: Breast cancer is a major and growing health challenge, and the leading cause of cancer in women. As population obesity rates increase, the number of new breast cancer diagnosis continues to rise. Despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. Although underlying susceptibility caused by mutation in the genes including BRCA1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates.

Alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. We have developed and tested a novel method to allow a standard 3T MRI scanner to perform quantitative 3D mapping of specific lipid molecules in the breast.

We will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.


Eligibility criteria: Inclusion Criteria:

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Women with BRCA1/2 genes:

* female 18-55 years old, premenopausal
* BRCA 1/2 gene carriers
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \< 30

Women with breast cancer (no obesity):

* females 18-55 years old, premenopausal
* confirmed diagnosis of invasive ductal carcinoma of the breast
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \< 30

Women with breast cancer (obesity):

* BMI \> 30
* otherwise as women with breast cancer

Women with obesity:

* females 18-55 years old, premenopausal
* not having any metabolic disorders (e.g., diabetes)
* not on any long term medications that may affect lipid metabolism (e.g., statins)
* BMI \> 30

Exclusion Criteria:

* females under 18 or over 55 years old, postmenopausal
* males
* have metabolic disorders (e.g., diabetes)
* on long term medications that may affect lipid metabolism (e.g., statins)
* contraindicated for MR investigation (poor renal function and metal implants)
* (for patients) concurrent cancer in other sites
* (for patients) started hormone treatment, chemotherapy or breast surgery
* non-English speakers

Primary outcomes:
measure: Amount of lipid composition in the breast
timeFrame: One hour
measure: Spatial distribution (skewness) of lipid composition in the breast
timeFrame: One hour
measure: Spatial distribution (entropy) of lipid composition in the breast
timeFrame: One hour
measure: Spatial distribution (kurtosis) of lipid composition in the breast
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Biomedical Imaging Centre
state: Aberdeenshire
Study officials:
References: