Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Imaging 3D and Spectroscopy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Masses. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues. [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Correlating the results of ultrasound-based breast cancer characterization to clinical outcomes. [Time frame: Up to 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT06175078 · 5587