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Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

RECRUITINGSponsored by University of Hawaii
Actively Recruiting
SponsorUniversity of Hawaii
Started2022-08-01
Est. completion2025-07
Eligibility
Age20 Years – 85 Years
SexFEMALE
Healthy vol.Accepted
Locations3 sites

Summary

The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.

Eligibility

Age: 20 Years – 85 YearsSex: FEMALEHealthy volunteers accepted
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.).

Conditions2

Breast CancerCancer

Locations3 sites

Florida

1 site
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, 33612
Emily Research Services Project Coordinator813-745-5501emily.amato@moffitt.org

Hawaii

2 sites
Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)
Hilo, Hawaii, 96720
Scott Grosskreutz, MD808-935-1825
The Queen's Medical Center
Honolulu, Hawaii, 96822
Richmond Clinical Research Associate808-691-7609riwong@queens.org

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