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NCT04841252 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Mayo Clinic.

Completed
Registry status
266
Enrollment target

NCT04841252: Completed study, sponsored by Mayo Clinic.

NCT04841252 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 266 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04841252 has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
266 participants
Enrollment target

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.

Primary Outcome

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 ope

Interventions

  • DEVICE FDA approved GE LOGIQ E9 (LE9) ultrasound
  • DEVICE Alpinion clinical ultrasound machine

Trial Details

FieldValue
Enrollment Target 266 participants
Start Date 2012-12-19
Est. Completion 2024-06-25
Mayo Clinic

2,844 total trials

What the finished NCT04841252 record still lists

NCT04841252 is an observational study that tracks outcomes without assigning an intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 2 interventions - of which FDA approved GE LOGIQ E9 (LE9) ultrasound is the first listed.

NCT04841252 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04841252 about?

NCT04841252 is a clinical study titled "Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method". 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 o...

What is the current status of trial NCT04841252?

This trial is currently completed. The enrollment target is 266 participants. The study started on 2012-12-19. Estimated completion is 2024-06-25.

What interventions are being tested in trial NCT04841252?

The interventions under investigation include: FDA approved GE LOGIQ E9 (LE9) ultrasound (DEVICE), Alpinion clinical ultrasound machine (DEVICE).

Who is sponsoring clinical trial NCT04841252?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04841252, the US trial registry maintained by the National Library of Medicine. NCT04841252 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.