Recruiting

Breast Cancer Analysis

Sponsor:

University of Hawaii

Code:

NCT05369546

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

q3CB

Study Details

Brief 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

Breast Cancer

Study ID

NCT05369546

Start date

Aug 1, 2022

Status verified date

Jan, 2023

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breast feeding
  • History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Quantify biological composition of lesions [ Time Frame: Baseline ]
  • Quantify morphology of lesions [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Recruiting

Tampa, Florida, United States, 33612

Contacts

Emily Research Services Project Coordinator

813-745-5501emily.amato@moffitt.org

Principal Investigator:

Bethany L Niell, MD

Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)

Recruiting

Hilo, Hawaii, United States, 96720

Contacts

Scott Grosskreutz, MD

808-935-1825

Principal Investigator:

Scott Grosskreutz, MD

The Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 96822

Contacts

Richmond Clinical Research Associate

808-691-7609riwong@queens.org

Principal Investigator:

Todd Seto, MD

More Information

Sponsor

University of Hawaii

Last update posted

Feb 2, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Hawaii on 2023-02-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.