Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

NCT06175078 | Not Yet Recruiting

• 1 other identifier: 5587
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the hypothesis that quantitative ultrasound techniques including spectroscopy may be used as a non-invasive biomarker for characterization of suspected breast cancers. The main goal is to select and identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize suspected breast cancers, as identified based on the histopathology reports on core biopsy specimens, surgery reports, or radiology reports. Primary endpoint will correlate quantitative ultrasound parameters to the histopathological properties, as determined from pathology reports on core biopsy specimens, surgery reports, or radiology reports. The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.

Conditions

Breast Cancer; Breast Masses

Keywords

Ultrasound Imaging 3D; Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.

  As a primary endpoint, correlate changes in ultrasound backscatter parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.

  Up to 2 years

Secondary Outcomes (1)

• Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes.

  Up to 5 years

Study Arms (1)

Patient with suspected breast cancer

Patients with suspected breast cancer will be recruited and scanned for this study. The results of ultrasound data analysis will be compared and correlated to the histopathology reports on routine core biopsy specimens, surgery reports, or radiology reports.

Device: Ultrasound Imaging 3D and Spectroscopy

Interventions

Ultrasound Imaging 3D and Spectroscopy DEVICE

Ultrasound imaging and spectroscopy will consist of collecting three dimensional data. Regions of interest in each of the tumour images and in the adjacent normal tissue will be selected for analysis.

Patient with suspected breast cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women or men with suspected breast cancer.

You may qualify if:

• Women or men with suspected breast cancer
• Patients should have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
• Receiving any other investigational agents.
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416) 480-5329; Gregory.Czarnota@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinician Scientist

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)