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Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

NCT05369546 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-02-02

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Queen's Medical Center

    collaborator OTHER

  • Hawaii Radiologic Associates, Ltd.

    collaborator UNKNOWN

  • University of Hawaii

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369546 on ClinicalTrials.gov