Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

NCT04050423 | Recruiting

• 1 other identifier: 232-2014
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Ultrasound; Spectroscopy; Characterization

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 5 years

Secondary Outcomes (1)

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

  Up to 5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory J Czarnota, PhD, MD

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Czarnota, PhD, MD

CONTACT

(416)480-6128; gregory.czarnota@sunnybrook.ca

Schontal Halstead

CONTACT

416-480-6100

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist and Clinician Scientist

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 8, 2019
• Study Start: September 23, 2014
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CA (1)