NCT04050423 Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
| NCT ID | NCT04050423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2014-09-23 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2014-09-23 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Our objective in this study is to identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize breast masses with high accuracy, as determined histopathologically. Breast cancer is the most frequent form of non-epithelial cancer diagnosed in women, with approximately 1.5 million new cases diagnosed annually worldwide. Accurate diagnosis and characterization of disease play an important role in therapy planning for breast cancer treatment. Currently, the gold standard method of tumour diagnosis is pathological examination of core biopsy specimens. However, the invasive core biopsies can cause post-surgical complications. Besides, some lesions require repeat biopsy due to sampling errors during the initial biopsy. Also X-ray mammography and ultrasound B-mode images, which are used by radiologists for breast examination, lack reliable information about micro-structural properties of tissues. There is an urgent need of a non-invasive imaging modality that can provide rapid and quantitative information for breast tumour characterization, in real time and at the patient bed. The main goal, as described above, is to select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively.
Eligibility 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.
Contact & Investigator
Gregory J Czarnota, PhD, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04050423 clinical trial?
This trial is open to participants of all sexes, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04050423 currently recruiting?
Yes, NCT04050423 is actively recruiting participants. Contact the research team at gregory.czarnota@sunnybrook.ca for enrollment information.
Where is the NCT04050423 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04050423 clinical trial?
NCT04050423 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Gregory J Czarnota, PhD, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 1,200 participants.
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