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Spots Global Cancer Trial Database for Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

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Trial Identification

Brief Title: Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

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

Study ID: NCT06175078

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Contact Details

Name: Gregory J Czarnota, PhD, MD

Affiliation: Sunnybrook Health Sciences Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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