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Clinical trialNCT05369546UnknownObservational

Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

SponsorUniversity of HawaiiEnrollment600Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • H. Lee Moffitt Cancer Center & Research Institute, Inc.

    Tampa, Florida, United States

    Bethany L Niell, MDDana K Ataya, MD
    Recruiting
  • Hawaii Radiology Associates, Ltd (east Hawaii Women'S Imaging Center)

    Hilo, Hawaii, United States

    Scott Grosskreutz, MD
    Recruiting
  • the Queen'S Medical Center

    Honolulu, Hawaii, United States

    Todd Seto, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Aug 2022
Primary completion
31 Jul 2025
Completion
31 Jul 2026
Last update posted
2 Feb 2023
Registered enrollment
600
Registry id
NCT05369546

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.