Ultrasound Imaging Study for Characterizing Suspected Breast Masses and Breast Cancer
Tests whether 3D ultrasound and spectroscopy can non-invasively characterize suspected breast cancers.
Key facts
- Who runs it
- Sunnybrook Health Sciences Centre
- Where
- Toronto, CanadaSee the site
- Trial code
- Registry title
- Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
- Status
- Not yet recruiting
- People taking part
- 200 people, planned
- Started
- Apr 2024
- Expected to end
- Apr 2029
- Type of study
- Observational
- Treatments tested
- Ultrasound Imaging 3D and Spectroscopy
- Record updated
- 27 December 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women or men with suspected breast cancer. They will have a 3D ultrasound scan to study breast masses.
- Sex
- Women and men can join.
- Disease stage
- Suspected breast cancer.
- Earlier treatment
- People who had chemotherapy, radiotherapy or major surgery in the 4 weeks before joining cannot join.
Main reasons for not taking part
- Chemotherapy, radiotherapy or major surgery within 4 weeks before joining
- Not recovered from side effects of treatment given more than 4 weeks before joining
- Taking any other investigational agents
- Any unstable condition that could risk safety or taking part in the study
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Women or men with suspected breast cancer
- Patients should have the ability to understand and the willingness to sign a written informed consent document
Who cannot take part
- 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
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Gregory J Czarnota, PhD, MDNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Treatment: Ultrasound Imaging 3D and Spectroscopy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigation of Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
- Plain-language title
- Ultrasound Imaging Study for Characterizing Suspected Breast Masses and Breast CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 December 2023