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

NCT04841252 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 266

Last updated 2026-04-01

No results posted yet for this study

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

Interventions

DEVICE

FDA approved GE LOGIQ E9 (LE9) ultrasound

Ultrasound

DEVICE

Alpinion clinical ultrasound machine

Ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Azra Alizad, M.D. · Mayo Clinic in Rochester

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-19
Primary Completion
2024-06-25
Completion
2024-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841252 on ClinicalTrials.gov