Using Ultrasound Scans to Characterize Breast Masses Without Biopsy
Studies ultrasound measurements to help tell apart breast masses in women.
Key facts
- Who runs it
- Sunnybrook Health Sciences Centre
- Where
- Toronto, CanadaSee the site
- Trial code
- Registry title
- Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
- Status
- Recruiting
- People taking part
- 1,200 people, planned
- Started
- 23 Sept 2014
- Expected to end
- Sept 2029
- Type of study
- Observational
- Record updated
- 14 December 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women or men with suspected breast cancer who can understand and sign a written consent form.
- Sex
- Women and men can join.
- Disease stage
- Suspected breast cancer.
- Earlier treatment
- Cannot have had chemotherapy, radiotherapy or major surgery within 4 weeks before joining.
Main reasons for not taking part
- Chemotherapy, radiotherapy or major surgery within 4 weeks before registering
- Not recovered from side effects of agents given more than 4 weeks before registration
- Receiving any other investigational agents
- Any unstable condition that could risk the person's safety or their ability to take part in the study
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Women or men with suspected breast cancer
- Patients should have the ability to understand and the willingness to sign a written Informed consent document
Who cannot take part
- 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
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Gregory J Czarnota, PhD, MDTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses
- Plain-language title
- Using Ultrasound Scans to Characterize Breast Masses Without BiopsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 December 2023