Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

Not yet recruiting

• Conditions: Breast Cancer; Breast Masses
• Interventions: Device: Ultrasound Imaging 3D and Spectroscopy

• Registration Number: NCT06175078
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

This project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. Patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. Results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27
• Study Start: 2024-04
• Primary Completion: 2026-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Receiving any other investigational agents.
3. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with suspected breast cancer	Ultrasound Imaging 3D and Spectroscopy	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.

Primary Outcome Measures

Name	Time	Method
Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes.	Up to 5 years	The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada