Novel Thermal Imaging Technique for Breast Screening

NCT ID: NCT05650086

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Biopsy

Subjects who are scheduled for biopsy will be enrolled.

Thermalytix

Intervention Type DEVICE

One-time Thermal imaging is performed for this cohort.

Cohort 2: Screening mammogram

Patients who underwent screening mammogram will be enrolled.

Thermalytix

Intervention Type DEVICE

One-time Thermal imaging is performed for this cohort.

Cohort 3: Diganostic mammogram

Subjects scheduled for diagnostic mammogram will be enrolled.

Thermalytix

Intervention Type DEVICE

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.

Thermalytix

Intervention Type DEVICE

One-time Thermal imaging is performed for this cohort.

Interventions

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Thermalytix

One-time Thermal imaging is performed for this cohort.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pavani Chalasani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00001233

Identifier Type: -

Identifier Source: org_study_id

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