Clinical trial · Observational
Towards Early Detection of Breast Cancer in High Risk Population
Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The investigators 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. The investigators 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood test | Biological | — | UNRESOLVED |
| MRI scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Women with BRCA1/2 genes
- interventionNames
- Diagnostic Test: MRI scan
- Biological: Blood test
- label
- Women with breast cancer
- interventionNames
- Diagnostic Test: MRI scan
- Biological: Blood test
- label
- Women with obesity
- interventionNames
- Diagnostic Test: MRI scan
- Biological: Blood test
Primary outcomes (4)
- measure
- Amount of lipid composition in the breast
- timeFrame
- One hour
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: \- 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
References
Publications (0)
Data not yet available