Novel Thermal Imaging Technique for Breast Screening

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05650086
• Other study ID #: STUDY00001233
• Status: Suspended
• Start date: November 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Thermalytix
One-time Thermal imaging is performed for this cohort.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of ThermalytixTM in detecting breast cancer	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	Sensitivity and specificity of ThermalytixTM in assessing need for biopsy	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
Secondary	Correlate normal screening mammogram results with ThermalytixTM results	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
Secondary	Correlate diagnostic mammogram results with ThermalytixTM results	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
Secondary	Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy	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
Secondary	Report patient experience with ThermalytixTM	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