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NCT Number: NCT06175078

Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Masses Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory J Czarnota, PhD, MD

CONTACT

[email protected]

(416) 480-5329

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Dec 18, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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