Breast CancerNCT05650086
Novel Thermal Imaging Technique for Breast Screening
An observational study of Breast Cancer, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Thermalytix
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for breast biopsy or mammogram
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85721
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Thermalytix
- Keywords
- Breast Cancer, Thermal Imaging, Artificial Intelligence, Breast Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermalytixDevice
One-time Thermal imaging is performed for this cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Biopsy | Subjects who are scheduled for biopsy will be enrolled. Receives: Device: Thermalytix | |
| Cohort 2: Screening mammogram | Patients who underwent screening mammogram will be enrolled. Receives: Device: Thermalytix | |
| Cohort 3: Diganostic mammogram | Subjects scheduled for diagnostic mammogram will be enrolled. Receives: Device: Thermalytix | |
| Cohort 4: Prior history of lympectomy, routine mammogram | Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled. Receives: Device: Thermalytix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 30 days
Secondary outcomes (5)
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.
Measured: Through study completion, an average of 30 days
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.
Measured: Through study completion, an average of 30 days
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.
Measured: Through study completion, an average of 30 days
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.
Measured: Through study completion, an average of 30 days
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.
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: PI has left the institution (University of Arizona Cancer Center).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavani Chalasani, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650086
- Sponsor's protocol ID
- STUDY00001233
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer
- ClinicalTrials.gov ID
- NCT05650086
- Acronym / sponsor ID
- STUDY00001233
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Thermal Imaging, Artificial Intelligence, Breast Imaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI has left the institution (University of Arizona Cancer Center).
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Biopsy | – | Device: ThermalytixSubjects who are scheduled for biopsy will be enrolled. |
| Cohort 2: Screening mammogram | – | Device: ThermalytixPatients who underwent screening mammogram will be enrolled. |
| Cohort 3: Diganostic mammogram | – | Device: ThermalytixSubjects scheduled for diagnostic mammogram will be enrolled. |
| Cohort 4: Prior history of lympectomy, routine mammogram | – | Device: ThermalytixSubjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for breast biopsy or mammogram
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermalytixOne-time Thermal imaging is performed for this cohort. | Device | Cohort 1: Biopsy, Cohort 2: Screening mammogram, Cohort 3: Diganostic mammogram, Cohort 4: Prior history of lympectomy, routine mammogram |
Primary outcome
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.
5 secondary outcomes
Sensitivity and specificity of ThermalytixTM in assessing need for biopsy
Time frame: 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
Correlate diagnostic mammogram results with ThermalytixTM results
Time frame: 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
Report patient experience with ThermalytixTM
Time frame: Through study completion, an average of 30 days
Results and safety
The study was stopped early (reason given: PI has left the institution (University of Arizona Cancer Center).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavani Chalasani, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI has left the institution (University of Arizona Cancer Center).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of ThermalytixTM in detecting breast cancer (time frame: Through study completion, an average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.