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Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

NCT ID: NCT06175078

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2029-04-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Breast Masses

Keywords

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Ultrasound Imaging 3D Spectroscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasound Imaging 3D and Spectroscopy

Intervention Type 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.

Interventions

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Ultrasound Imaging 3D and Spectroscopy

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gregory Czarnota

Radiation Oncologist and Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory J Czarnota, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Gregory J Czarnota, PhD, MD

Role: CONTACT

Phone: (416) 480-5329

Email: [email protected]

Other Identifiers

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5587

Identifier Type: -

Identifier Source: org_study_id