Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04050423
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 119.3
• Patients Per Site Per Month: 5

Study Details

Study Description

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	Intervention/Treatment	Phase
Breast Cancer

Study Design

• Study Type: Observational
• Anticipated 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: Sep 23, 2014
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Breast Characterization

Outcome Measures

Primary Outcome Measures

1. Measuring quantitative ultrasound backscatter and image texture parameters of benign and malignant breast lesions [Up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT04050423
• Other Study ID Numbers: 232-2014
• First Posted: Aug 8, 2019
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Gregory Czarnota, Radiation Oncologist and Clinician Scientist, Sunnybrook Health Sciences Centre: Ultrasound; Spectroscopy; Characterization

Study Results

No Results Posted as of Aug 20, 2020