Recruiting

NCT Number: NCT04050423

Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Gregory J Czarnota, PhD, MD

CONTACT

[email protected]

(416)480-6128

Gregory J Czarnota, Phd, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women or men with suspected breast cancer
Patients should have the ability to understand and the willingness to sign a written Informed consent document.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively

Time frame: Up to 5 years

Correlate quantitative ultrasound parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.

Secondary outcomes

Results of ultrasound-based breast cancer characterization and clinical outcomes.

Time frame: Up to 5 years

Correlating the results of ultrasound-based breast cancer characterization.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory J Czarnota, PhD, MD

CONTACT

[email protected]

(416)480-6128

Schontal Halstead

CONTACT

416-480-6100 ext. 89533

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2025
Study completion: 2029
First posted: Aug 8, 2019
Registry last updated: Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting