Using ultrasound imaging and spectroscopy to analyze breast masses
Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
This study is testing if special ultrasound techniques can help doctors better understand and identify breast lumps in patients suspected of having breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04050423 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify optimal quantitative ultrasound parameters for non-invasively characterizing breast masses with high accuracy, as confirmed by histopathological analysis. It involves imaging patients with suspected breast cancer using ultrasound and analyzing the data through quantitative techniques and textural analysis. The results will be compared to histopathological characteristics from biopsy and surgery reports to estimate a reliable ultrasound-based biomarker for breast cancer characterization.
Who should consider this trial
Good fit: Ideal candidates include men and women with suspected breast cancer who can provide informed consent.
Not a fit: Patients who have undergone recent chemotherapy, radiotherapy, or major surgery, or those with unstable conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for accurately diagnosing and characterizing breast cancer, reducing the need for invasive biopsies.
How similar studies have performed: While there have been studies exploring ultrasound imaging for breast cancer, this specific combination of ultrasound imaging and spectroscopy for characterization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gregory J Czarnota, PhD, MD — Sunnybrook Health Science Centre
- Study coordinator: Gregory J Czarnota, PhD, MD
- Email: gregory.czarnota@sunnybrook.ca
- Phone: (416)480-6128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.