Clinical trial NCT06175078: 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 type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Breast Masses
Keywords: Ultrasound Imaging 3D
Spectroscopy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women or men with suspected breast cancer.

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 criteria: 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.

Primary outcomes:
measure: Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes.
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gregory J Czarnota, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: