Clinical trial Recruiting at 1 site Observational

Using ultrasound imaging and spectroscopy to analyze breast masses

Official title: Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

Run by Sunnybrook Health Sciences Centre · NCT04050423 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment1200 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedSeptember 23, 2014
Main results expectedSeptember 2025
Study endsSeptember 2029
Registry record updatedDecember 14, 2023
Trial IDNCT04050423 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men and women with suspected breast cancer who can provide informed consent.

Probably not a fit

Patients who have undergone recent chemotherapy, radiotherapy, or major surgery, or those with unstable conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While there have been studies exploring ultrasound imaging for breast cancer, this specific combination of ultrasound imaging and spectroscopy for characterization is relatively novel.

Who can join: the full rules

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 it's running

  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.