NCT04050423Recruiting
Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
Source: ClinicalTrials.gov · Last updated 14 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 22 Jul 2019
- Start date
- 23 Sept 2014
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Childhood cancers
- NCT number
- NCT04050423
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 23 Sept 2014 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Who the study is looking for
- Women or men with suspected breast cancer
- Patients should have the ability to understand and the willingness to sign a written Informed consent document.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.