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Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

NCT ID: NCT04050423

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-23

Study Completion Date

2029-09-30

Brief Summary

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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.

Detailed Description

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This project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. Patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. Results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with their histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports, available from patient charts. From this data we will potentially estimate the best hybrid ultrasound-based biomarker that can characterize suspected breast cancers, noninvasively.

Conditions

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Breast Cancer

Keywords

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Ultrasound Spectroscopy Characterization

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gregory Czarnota

Radiation Oncologist and Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory J Czarnota, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Science Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Gregory J Czarnota, PhD, MD

Role: CONTACT

Phone: (416)480-6128

Email: [email protected]

Schontal Halstead

Role: CONTACT

Phone: 416-480-6100

Facility Contacts

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Gregory J Czarnota, PhD, MD

Role: primary

Other Identifiers

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232-2014

Identifier Type: -

Identifier Source: org_study_id