Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
H. Lee Moffitt Cancer Center & Research Institute, Inc.
RECRUITING
Tampa
Hawaii
Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)
RECRUITING
Hilo
The Queen's Medical Center
RECRUITING
Honolulu
Contact Information
Primary
John A Shepherd, PhD
johnshep@hawaii.edu
808-440-5234
Backup
Leila Kazemi
lkazemi@hawaii.edu
808-440-5231
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 600
Related Therapeutic Areas
Sponsors
Collaborators: Queen's Medical Center, Hawaii Radiologic Associates, Ltd., H. Lee Moffitt Cancer Center and Research Institute
Leads: University of Hawaii

This content was sourced from clinicaltrials.gov