Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method

NCT04841252 | Completed FDA Device

• 2 other identifiers: 12-009399R01CA168575
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

FDA approved GE LOGIQ E9 (LE9) ultrasound DEVICE

Ultrasound

Alpinion clinical ultrasound machine DEVICE

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Azra Alizad, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 12, 2021
• Study Start: December 19, 2012
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)