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

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

Inclusion Criteria2

  • 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 Criteria2

  • 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.).

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

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NCT05369546


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