RECRUITING

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Quick Facts

Study Start:2022-08-01
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05369546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 85 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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".
  2. * Have not had biopsy
  1. * Pregnant or breast feeding
  2. * History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).

Contacts and Locations

Study Contact

John A Shepherd, PhD
CONTACT
808-440-5234
johnshep@hawaii.edu
Leila Kazemi
CONTACT
808-440-5231
lkazemi@hawaii.edu

Principal Investigator

John A Shepherd, PhD
PRINCIPAL_INVESTIGATOR
University of Hawaii Cancer Research Center

Study Locations (Sites)

H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, 33612
United States
Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)
Hilo, Hawaii, 96720
United States
The Queen's Medical Center
Honolulu, Hawaii, 96822
United States

Collaborators and Investigators

Sponsor: University of Hawaii

  • John A Shepherd, PhD, PRINCIPAL_INVESTIGATOR, University of Hawaii Cancer Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer