Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

NCT05369546 | Recruiting

• 1 other identifier: SHEPHERD-2021-2
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Quantify biological composition of lesions

  Quantify the biological composition (lipid/water/protein) of suspicious lesions.

  Baseline

• Quantify morphology of lesions

  Quantify morphology/texture (radiomics) of suspicious lesions.

  Baseline

Secondary Outcomes (2)

• Comparison of radiologists' image interpretations with and without q3CB signatures

  Baseline

• Sensitivity and Specificity of readers' responses for the BI-RADs assessment categories

  Baseline

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.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All 600 women will be recruited and enrolled from one of three sites: Queen's Medical Center (Honolulu, HI), East Hawaii Women's Imaging Center (Hilo, HI), and H. Lee Moffitt Cancer Center \& Research Institute (Tampa, FL).

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Hawaii: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• Queen's Medical Center: collaborator
• Hawaii Radiologic Associates, Ltd.: collaborator

Study Sites (3)

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

Tampa, Florida, 33612, United States

RECRUITING

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

Hilo, Hawaii, 96720, United States

RECRUITING

The Queen's Medical Center

Honolulu, Hawaii, 96822, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John A Shepherd, PhD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A Shepherd, PhD

CONTACT

808-440-5234; johnshep@hawaii.edu

Leila Kazemi

CONTACT

808-440-5231; lkazemi@hawaii.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 11, 2022
• Study Start: August 1, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (3)