Breast Cancer Clinical Trial
— SAVEOfficial title:
Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.
Status | Active, not recruiting |
Enrollment | 266 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation. Exclusion Criteria: - No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices. - Only include patients with masses detectable under ultrasound. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses. | Assessed using a two-phase design. The first phase will be the development aspects to determine a candidate threshold for T1 that produces Optimal diagnostic accuracy as quantified by the largest diagnostic odds ratio. The second phase of the study will be to apply this candidate threshold to the validation sample enrolled as a part of the specific aim to ensure diagnostic utility. For both phases of the analysis, overall diagnostic accuracy will be quantified by the area under the receiver operating characteristics (ROC) curve. |
Before biopsy or at least 2 weeks post biopsy | |
Primary | Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list. | The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance | Before biopsy or at least 2 weeks post biopsy |
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