RecruitingNCT05369546

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Sponsor

University of Hawaii

Enrollment

600 participants

Start Date

Aug 1, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a better way to analyze breast abnormalities found on mammograms using advanced imaging and AI. Researchers want to study the makeup of suspicious breast lesions to improve accuracy in distinguishing cancer from benign (non-cancerous) growths. **You may be eligible if...** - You have had a recent diagnostic mammogram rated BI-RADS 4 (suspicious) or 5 (highly suspicious for cancer) by a radiologist - You have not yet had a biopsy of the suspicious area **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of breast cancer or have had a mastectomy with systemic treatment (such as chemotherapy or hormone therapy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTq3CB

The q3CB/ncCEM/DBT acquisition protocol consists of a combination of DBT volume reconstructions and projection dual-energy mammograms acquired with a clinical contrast enhanced mammography (CEM) protocol, without contrast administration agent.

Locations(3)

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, United States

Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)

Hilo, Hawaii, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

View Full Details on ClinicalTrials.gov

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