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NCT05650086 · ClinicalTrials.gov registry record

Novel Thermal Imaging Technique for Breast Screening

A clinical trial, sponsored by University of Arizona.

Terminated
Registry status
115
Enrollment target

NCT05650086: Clinical Trial study, sponsored by University of Arizona.

NCT05650086 is a clinical trial that was terminated before completion, run by University of Arizona. The registered enrollment target is 115 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05650086 was terminated before completion, sponsored by University of Arizona.

TERMINATED
Registry status
115 participants
Enrollment target

Study Summary

This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.

Primary Outcome

Determine sensitivity and specificity of ThermalytixTM in detecting breast cancer in patients scheduled to undergo breast biopsy (Cohort 1). The sensitivity and specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target sensitivity and specificity, and the resulting confidence intervals.

Interventions

  • DEVICE Thermalytix

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2022-11-15
Est. Completion 2023-06-30
University of Arizona

349 total trials

Why NCT05650086 stopped before completion

NCT05650086 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Thermalytix is the first listed.

NCT05650086 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05650086 about?

NCT05650086 is a clinical study titled "Novel Thermal Imaging Technique for Breast Screening". This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat si...

What is the current status of trial NCT05650086?

This trial is currently terminated. The enrollment target is 115 participants. The study started on 2022-11-15. Estimated completion is 2023-06-30.

What interventions are being tested in trial NCT05650086?

The interventions under investigation include: Thermalytix (DEVICE).

Who is sponsoring clinical trial NCT05650086?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05650086, the US trial registry maintained by the National Library of Medicine. NCT05650086 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.