Clinical trial NCT05650086: Novel Thermal Imaging Technique for Breast Screening
Official title: A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Breast Cancer
Thermal Imaging
Artificial Intelligence
Breast Imaging
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for breast biopsy or mammogram

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of ThermalytixTM in detecting breast cancer
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Sensitivity and specificity of ThermalytixTM in assessing need for biopsy
timeFrame: Through study completion, an average of 30 days
measure: Correlate normal screening mammogram results with ThermalytixTM results
timeFrame: Through study completion, an average of 30 days
measure: Correlate diagnostic mammogram results with ThermalytixTM results
timeFrame: Through study completion, an average of 30 days
measure: Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy
timeFrame: Through study completion, an average of 30 days
measure: Report patient experience with ThermalytixTM
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References: