Actively Recruiting

Age: 20Years - 85Years
FEMALE
NCT05369546

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Led by University of Hawaii · Updated on 2023-02-02

600

Participants Needed

3

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

University of Hawaii

Lead Sponsor

H

H. Lee Moffitt Cancer Center and Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Who Can Participate

Age: 20Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Had a recent diagnostic mammogram with a BI-RADS score of 4 or 5 assigned by a radiologist
  • Have not had a breast biopsy
  • Female participants aged between 20 and 85 years
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • History of breast cancer or mastectomy with systemic therapy such as chemotherapy or hormone treatment

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Trial Site Locations

Total: 3 locations

1

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

Tampa, Florida, United States, 33612

Actively Recruiting

2

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

Hilo, Hawaii, United States, 96720

Actively Recruiting

3

The Queen's Medical Center

Honolulu, Hawaii, United States, 96822

Actively Recruiting

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Research Team

J

John A Shepherd, PhD

CONTACT

L

Leila Kazemi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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