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RECRUITING
NCT05369546

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Sponsor: University of Hawaii

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2022-08-01

Completion Date

2026-07

Last Updated

2023-02-02

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

q3CB

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