Novel Thermal Imaging Technique for Breast Screening

NCT05650086 | Terminated

• 1 other identifier: STUDY00001233
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Thermal Imaging; Artificial Intelligence; Breast Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Sensitivity and specificity of ThermalytixTM in assessing need for biopsy

  Through study completion, an average of 30 days

• Correlate normal screening mammogram results with ThermalytixTM results

  Through study completion, an average of 30 days

• Correlate diagnostic mammogram results with ThermalytixTM results

  Through study completion, an average of 30 days

• Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy

  Through study completion, an average of 30 days

• Report patient experience with ThermalytixTM

  Through study completion, an average of 30 days

Study Arms (4)

Cohort 1: Biopsy

Subjects who are scheduled for biopsy will be enrolled.

Device: Thermalytix

Cohort 2: Screening mammogram

Patients who underwent screening mammogram will be enrolled.

Device: Thermalytix

Cohort 3: Diganostic mammogram

Subjects scheduled for diagnostic mammogram will be enrolled.

Device: Thermalytix

Cohort 4: Prior history of lympectomy, routine mammogram

Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled.

Device: Thermalytix

Interventions

Thermalytix DEVICE

One-time Thermal imaging is performed for this cohort.

Cohort 1: Biopsy; Cohort 2: Screening mammogram; Cohort 3: Diganostic mammogram; Cohort 4: Prior history of lympectomy, routine mammogram

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for breast biopsy or mammogram

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pavani Chalasani, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: November 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)