Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Hawaii
Study ID
NCT05369546
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • q3CB — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
Jan 2023
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Quantify biological composition of lesions [ Time Frame: Baseline ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research Institute, Inc.TampaFlorida33612
Emily Research Services Project Coordinator
[email protected]
813-745-5501
Bethany L Niell, MD (PRINCIPAL_INVESTIGATOR)
Dana K Ataya, MD (PRINCIPAL_INVESTIGATOR)
Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)HiloHawaii96720
Scott Grosskreutz, MD
808-935-1825
Scott Grosskreutz, MD (PRINCIPAL_INVESTIGATOR)
The Queen's Medical CenterHonoluluHawaii96822
Richmond Clinical Research Associate
[email protected]
808-691-7609
Todd Seto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
H. Lee Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLHawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)· Hilo, HIThe Queen's Medical Center· Honolulu, HI

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