Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
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ClinicalTrials.gov Identifier: NCT04050423 |
Recruitment Status :
Recruiting
First Posted : August 8, 2019
Last Update Posted : August 20, 2020
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses |
Actual Study Start Date : | September 23, 2014 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2024 |

Group/Cohort |
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Breast Characterization |
- Measuring quantitative ultrasound backscatter and image texture parameters of benign and malignant breast lesions [ Time Frame: Up to 5 years ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050423
Contact: Gregory J Czarnota, PhD, MD | (416)480-6128 | gregory.czarnota@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Gregory J Czarnota, PhD, MD (416)480-6128 gregory.czarnota@sunnybrook.ca | |
Principal Investigator: Gregory J Czarnota, Phd, MD |
Responsible Party: | Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT04050423 |
Other Study ID Numbers: |
232-2014 |
First Posted: | August 8, 2019 Key Record Dates |
Last Update Posted: | August 20, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ultrasound Spectroscopy Characterization |