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Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04050423
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 20, 2020
Information provided by (Responsible Party):
Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre

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.

Condition or disease
Breast Cancer

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Breast Characterization

Primary Outcome Measures :
  1. Measuring quantitative ultrasound backscatter and image texture parameters of benign and malignant breast lesions [ Time Frame: Up to 5 years ]

Information from the National Library of Medicine

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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
Study Population
Both men and women and members of all races and ethnic groups are eligible for this trial.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04050423

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Contact: Gregory J Czarnota, PhD, MD (416)480-6128

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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gregory J Czarnota, PhD, MD    (416)480-6128   
Principal Investigator: Gregory J Czarnota, Phd, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre: