Novel Thermal Imaging Technique for Breast Screening

November 21, 2023 updated by: University of Arizona

A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for breast biopsy or mammogram

Description

Inclusion Criteria:

  • Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  • Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  • Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
  • Age ≥ 21 years
  • Cohort specific criteria
  • Cohort 1: Be scheduled for biopsy
  • Cohort 2: Had a normal screening mammogram within 3 months of study enrollment
  • Cohort 3: Be scheduled for diagnostic mammogram
  • Cohort 4: History of breast cancer, s/p lumpectomy and be scheduled for routine mammogram

Exclusion Criteria:

  • Cohort specific criteria
  • Cohort 1: Previous biopsies in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants
  • Cohort 2: prior history of breast surgeries including implants
  • Cohort 3: Already underwent a biopsy in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants
  • Cohort 4: surgery <1 year, h/o mastectomy with reconstruction
  • Unable to complete study related procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: Biopsy
Subjects who are scheduled for biopsy will be enrolled.
Device: Thermalytix
One-time Thermal imaging is performed for this cohort.
Cohort 2: Screening mammogram
Patients who underwent screening mammogram will be enrolled.
Device: Thermalytix
One-time Thermal imaging is performed for this cohort.
Cohort 3: Diganostic mammogram
Subjects scheduled for diagnostic mammogram will be enrolled.
Device: Thermalytix
One-time Thermal imaging is performed for this cohort.
Cohort 4: Prior history of lympectomy, routine mammogram
Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled.
Device: Thermalytix
One-time Thermal imaging is performed for this cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of ThermalytixTM in detecting breast cancer
Time Frame: Through study completion, an average of 30 days
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.
Through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of ThermalytixTM in assessing need for biopsy
Time Frame: Through study completion, an average of 30 days
To determine accuracy of ThermalytixTM in assessing need for biopsy in patients who are found to have abnormal screening mammogram. Cohort 1 subjects will be used to determine this endpoint. 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.
Through study completion, an average of 30 days
Correlate normal screening mammogram results with ThermalytixTM results
Time Frame: Through study completion, an average of 30 days
To compare ThermalytixTM with screening mammogram in healthy subjects undergoing routine screening. Cohort 2 will be used to assess this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.
Through study completion, an average of 30 days
Correlate diagnostic mammogram results with ThermalytixTM results
Time Frame: Through study completion, an average of 30 days
To compare ThermalytixTM with diagnostic mammogram in subjects who underwent diagnostic mammogram. Cohort 3 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.
Through study completion, an average of 30 days
Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy
Time Frame: Through study completion, an average of 30 days
To compare ThermalytixTM with mammogram result (screening or diagnostic) in women who underwent lumpectomy. Cohort 4 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals.
Through study completion, an average of 30 days
Report patient experience with ThermalytixTM
Time Frame: Through study completion, an average of 30 days
Patient experience with ThermalytixTM will be documented via questionnaires. On a scale of 1-5, patients will document their experience during their mammogram and Thermalytix exam; in general, higher values indicate a better outcome.
Through study completion, an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Pavani Chalasani, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Thermalytix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe