Improving breast cancer diagnosis through advanced imaging techniques
Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
This study is testing a new imaging technique to see if it can help doctors better identify suspicious breast lumps in women who need a biopsy, potentially reducing the number of unnecessary procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Hawaii Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 3 sites (Tampa, Florida and 2 other locations) |
| Trial ID | NCT05369546 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the identification of suspicious breast lesions in women recommended for biopsy by utilizing innovative imaging protocols to acquire multispectral images. The approach focuses on measuring the lipid/water/protein composition of these lesions, hypothesizing that this combined with morphological and textural analysis will improve specificity for breast cancer diagnosis compared to conventional imaging methods. The study will compare biopsy yields with and without the use of this new imaging analysis technique, known as q3CB, to determine its effectiveness in reducing unnecessary biopsies.
Who should consider this trial
Good fit: Ideal candidates are women with dense breasts who have received a BI-RADS score of 4 or 5 on a recent diagnostic mammogram and have not undergone a biopsy.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of breast cancer or mastectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate breast cancer diagnoses and a reduction in unnecessary biopsies for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic accuracy through advanced imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Had a recent diagnostic mammogram with a BI-RADS diagnostic score 4 or 5 assigned by a radiologist (BIRADS are standardized mammography assessment categories: 4 is for "Suspicious abnormality", 5 is for "Highly suggestive of malignancy". * Have not had biopsy Exclusion Criteria: * Pregnant or breast feeding * History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).
Where this trial is running
Tampa, Florida and 2 other locations
- H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States (Recruiting)
- Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center) — Hilo, Hawaii, United States (Recruiting)
- The Queen's Medical Center — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: John A Shepherd, PhD — University of Hawaii Cancer Research Center
- Study coordinator: John A Shepherd, PhD
- Email: johnshep@hawaii.edu
- Phone: 808-440-5234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.