Breast CancerThermoBreastNCT06266026
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography.
A study testing ThermoBreast - AI-based evaluation of dynamic breast thermography imaging in people with Breast Cancer, run by ThermoMind Ltd. at 1 site in Germany.
Trial summary
Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ThermoBreast - AI-based evaluation of dynamic breast thermography imaging
- How many people
- 28,000 participants
- Where
- 1 siteGermany
- Study dates
- 11 Dec 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening cohort
- Female subjects aged 40 to 74 years old (inclusive) presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines
- Subjects who are willing to give written informed consent for study participation
- Subjects who are able to understand the character and individual consequences of the clinical trial and who are ready to comply with the study related visits and procedures
- High-risk screening cohort
- Female subjects aged 18 and above presenting for intensified high-risk breast cancer screening due to genetic predisposition or family history according to national/regional guidelines
Show all 12Show fewer
- Subjects who are willing to give written informed consent for study participation
- Subjects who are able to understand the character and individual consequences of the clinical trial and who are ready to comply with the study related visits and procedures
- Diagnostics cohort
- Female subjects aged 18 and above presenting for intensified aftercare after a history of breast cancer, patients with symptoms (nipple discharge, breast lump based on physician physical exam or self-breast exam), patients who were referred for additional examination (MRI, Ultrasound, fine-needle aspiration cytology (FNAC) or biopsy) based on suspicious imaging findings in either breast
- Subjects who are willing to give written informed consent for study participation
- Subjects who are able to understand the character and individual consequences of the clinical trial and ready to comply with the study related visits and procedures
Who cannot join
- (High-risk) Screening and Diagnostics cohort
- Subjects who are pregnant or lactating
- Subjects who have undergone lumpectomy or mastectomy in the last 4 months at the time of study enrollment
- Subjects who have undergone cancer therapy (chemotherapy, start of hormonal therapy, radiotherapy, surgery) in the last 4 months at the time of study enrollment
- Subjects who have undergone a breast biopsy in the last 2 months at the time of study enrollment
- No subject will be allowed to enrol in this trial more than once.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital
Heidelberg
André Pfob, MD
About this study
Official title: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. An International, Multicenter, Prospective Development and Validation Trial.
Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.
Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.
To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring.
Read the detailed description
This study is designed as a multicenter, prospective, blinded, three cohorts, diagnostic trial. Patients will be recruited at 11 centers in France, Germany, Ireland, Israel, Slovenia, Lithuania, and the US.
The primary objective is to compare the diagnostic performance of advanced image processing AI models to automatically predict breast malignancy based on thermograms and individual patient data collected during breast examination (ThermoBreast) with routine breast cancer screening and imaging.
The study population consists of women undergoing routine screening for breast cancer or diagnostic evaluation of suspicious breast masses. The study will recruit women into three cohorts: Screening cohort, High-Risk Screening, and Diagnostics cohort. Participants recruited for the study will be assigned to a dedicated cohort based on the reason of the visit.
There will be two visits for study participants, partially including study specific and routine procedures, who meet the inclusion criteria in the screening procedure.
The first trial visit (V1.1) will take place to provide the patient with detailed information on the study, its aims, the ThermoBreast procedure, and its risks. In- and exclusion criteria will be checked. Informed consent will be obtained. If the patient consents, the study specific ThermoBreast procedure (index test) and a study specific questionnaire regarding user experience will be performed. Moreover, the patient will undergo the routine first breast cancer screening round (screening cohort) or the routine first breast cancer diagnostics round (diagnostic cohort) according to national guidelines which serve as a reference test. In the screening cohort, the patient may undergo routine breast diagnostics following an irregular first screening round (V1.2) according to national guidelines.
The second trial visit (V2) serves as a follow-up visit for the reference test - no study specific interventions will be performed here. Patients will undergo routine breast cancer screening or diagnostics according to national guidelines which serve as a reference test. In the screening cohort, the patient may undergo routine breast diagnostics following an irregular second screening round (V2.2) according to national guidelines. No study specific interventions will be performed during this trial visit.
There will be no randomization within this study design. The findings of thermal screening will not be disclosed to patients and physicians, to avoid any anxiety or influence on the physicians' decision-making, as the proposed method is under study and development. The ThermoBreast system will only record the thermal imaging but will not automatically display any final assessment with respect to risk of breast cancer.
AI-based evaluation of dynamic breast thermography imaging (=ThermoBreast, index test) will serve as the outcome measure. The ThermoBreast evaluation will be performed independently of the routine breast diagnostic evaluation. Some baseline risk variables (e.g. patient age, hormonal status) may be included in the ThermoBreast evaluation. ThermoBreast will provide a risk score for invasive breast cancer on a per-patient basis (not per breast).
Routine breast diagnostics will serve as a reference test against which the ThermoBreast outcome will be compared. Depending on national guidelines and clinical scenarios, routine breast cancer diagnostics can consist of several routine procedures, including clinical examination, ultrasound, mammography, tomosynthesis, MRI, follow-up imaging, biopsy, surgical excision, and histopathologic evaluation. All procedures will be performed as indicated and specified by the respective, current national guidelines.
The AI-based evaluation will use state-of-the-art image analysis techniques. The algorithm will be trained on data acquired during the training phase of the trial. For the second 6 month validation phase of the trial, a data lock will ensure that outcomes with respect to the reference test (routine breast diagnostics) will not be available anymore for the team responsible for the ThermoBreast algorithm development.
A positive reference test is defined as histopathologic diagnosis of invasive breast cancer.
A negative reference test is defined as
- For the hypothesis without follow-up: a first study visit without biopsy indication (breast imaging BI-RADS 3,2 or 1), or a benign histopathologic evaluation.
- For the hypothesis with follow-up: two regular study visits (breast imaging BI-RADS 2 or 1), a regular follow-up imaging after an irregular screening/imaging finding (BI-RADS 3 followed by BI-RADS 2 or 1), or a benign histopathologic evaluation.
Analyses will be performed on a per-patient basis. In case of multiple breast masses per patient, the one with the highest risk of breast cancer or histopathological confirmed invasive breast cancer will be considered for the primary efficacy analysis
- Conditions
- Breast Cancer
- Being tested
- ThermoBreast - AI-based evaluation of dynamic breast thermography imaging
- Keywords
- Artificial Intelligence, Thermography, breast imaging, breast diagnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoBreast - AI-based evaluation of dynamic breast thermography imagingDiagnostic test
Also called ThermoMind Vision One Device
Index test: AI-based evaluation of dynamic breast thermography imaging (ThermoBreast). The ThermoBreast evaluation will be performed independently of the routine breast cancer diagnostic evaluation. Some baseline risk variables (e.g. patient age, hormonal status) may be included in the ThermoBreast evaluation.
Reference test: Routine breast diagnostics will serve as a reference test against which the ThermoBreast outcome will be compared. Depending on national guidelines and clinical scenarios, routine breast cancer diagnostics can consist of several routine procedures, including clinical examination, ultrasound, mammography, tomosynthesis, MRI, follow-up imaging, biopsy, surgical excision, and histopathologic evaluation. All procedures will be performed as indicated and specified by the respective, current national guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (true-positive rate)
As our primary outcome we will use true-positive ThermoBreast results, i.e. detected invasive breast cancer by ThermoBreast (=index test) compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging (=reference test). We will report this outcome as the true-positive rate (=TPR, rate of patients with non-detected invasive breast cancer by ThermoBreast compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging) which is a commonly used and validated measure in diagnostic studies.
Measured: up to 2 years of follow-up
Specificity (true-negative rate)
As a co-primary outcome we will measure the specificity of the ThermoBreast screening modality. The specificity will be defined as the rate of true-negative ThermoBreast results, i.e., the number of correctly identified absence of invasive breast cancer by ThermoBreast, when compared to the number of absence of histopathologically confirmed invasive breast cancer or regular follow-up imaging during routine breast cancer screening/imaging. This outcome will be reported as the true-negative rate (=TNR, rate of patients for whom ThermoBreast correctly identifies the absence of invasive breast cancer in alignment with the results from routine breast cancer screening/imaging).
Measured: up to 2 years of follow-up
Secondary outcomes (20)
Cancer detection rate
To evaluate the invasive breast cancer detection rate per 1000 women screened of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Detection rate of ductal carcinoma in situ (DCIS)
Number of women with ThermoBreast screening-detected ductal carcinoma in situ (if the pT category of the TNM classification falls into the category pTis) divided by the number of all women screened.
Measured: up to 2 years of follow-up
Detection rate of tumor category pT1
Number of women with ThermoBreast screening-detected invasive breast cancers of the category pT1 divided by the number of all women screened. A screening-detected breast cancer is classified as breast cancer of tumor category pT1 if tumor size is ≤ 20 mm in greatest dimension and the respective pT subcategory of the pTNM classification is one of the following: pT1mic, pT1a, pT1b, pT1c, pT1.
Measured: up to 2 years of follow-up
Recall rate
To evaluate the recall rate per 100 women screened of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Sensitivity
To evaluate the sensitivity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Specificity
To evaluate the specificity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Positive-predictive value
To evaluate the positive-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Negative-predictive value
To evaluate the negative-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
Measured: up to 2 years of follow-up
Diagnostic performance in the three trial cohorts
To compare the diagnostic performance of ThermoBreast with routine breast cancer screening and imaging rate within the three cohorts ( (1) screening cohort, (2) high-risk screening cohort (3) diagnostics cohort) in terms of sensitivity, specificity, negative-predictive value, positive predictive value, recall rate, and cancer detection rate
Measured: up to 2 years of follow-up
Proportion of breast quadrant localization
Number of women with correct localization of breast masses by ThermoBreast (measured in breast quadrants: upper outer, upper inner, lower outer, lower inner) divided by all women with breast masses.
Measured: Screening visit
Proportion of correct histopathologic subtype identification
Number of women with correct diagnosis of histopathologic subtype by ThermoBreast (invasive-ductal, invasive-lobular, medullary, tubular, papillary, metaplastic, in-situ) divided by all women with the respective histopathologic subtype.
Measured: up to 2 years of follow-up
Proportion of correct tumorbiologic subtype identification
Number of women with correct diagnosis of tumorbiologic subtype by ThermoBreast (hormon receptor positive/ HER2neu negative, hormon receptor positive, HER2neu positive, hormon receptor negative/HER2neu positive, triple-negative breast cancer) divided by all women with the respective tumorbiologic subtype.
Measured: up to 2 years of follow-up
Proportion of correct axillary lymph node involvement identification
The compare the diagnostic performance of ThermoBreast to axillary ultrasound in the detection of axillary lymph node metastasis in terms of sensitivity and specificity
Measured: up to 2 years of follow-up
Effect of hormonal status on diagnostic performance
To compare the diagnostic performance of ThermoBreast and routine breast imaging modalities in women with pre-,peri-,and post-menopausal status in terms of sensitivity, specificity, negative-predictive value, positive predictive value, recall rate, and cancer detection rate
Measured: up to 2 years of follow-up
Effect of breast density on diagnostic performance
To compare the diagnostic performance of ThermoBreast and routine breast imaging modalities in women with different breast densities (ACR A-D) in terms of sensitivity, specificity, negative-predictive value, positive predictive value, recall rate, and cancer detection rate.
Measured: up to 2 years of follow-up
Effect of ethnicity on diagnostic performance
To compare the diagnostic performance of ThermoBreast and routine breast imaging modalities in women with different ethnicity in terms of sensitivity, specificity, negative-predictive value, positive predictive value, recall rate, and cancer detection rate
Measured: up to 2 years of follow-up
Timing of ThermoBreast
To estimate the possibility of ThermoBreast to replace versus precede routine breast cancer screening/imaging as an additional imaging technique in terms of diagnostic performance
Measured: up to 2 years of follow-up
Screening time
To estimate the possibility to reduce the screening time by evaluating the effect of screening duration on the performance of ThermoBreast
Measured: Screening visit
Cost-effectiveness
To evaluate the cost-effectiveness of ThermoBreast for breast cancer screening and diagnosis. A cost per QALY analysis will be conducted.
Measured: up to 2 years of follow-up
Lived Experience
The goal is to measure the difference between thermography and mammography by patients' self-assessment. Concretely, we will focus on the following areas: trust in the modality, perceived pain and discomfort, intention to use and willingness to pay. For trust and reliability, we are going to use the existing Likert scale made by Cahour and Forzy (2009). Perceived pain and comfort will be measured via the Likert scale made by indication of pain in the bodymap (van der Grinten, 1991) and the pain intensity scale (Jensen and Karoly, 1986). The willingness to pay question is based on van Helvoort-Postulart et al.'s study (2008). The results will be assessed by ANOVA and t-test by evaluating differences between thermography and mammography, as well as expectations before the test and the actual experience after the test.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start11 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ThermoMind Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assuta Medical Centers Ltd., Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Institut Gustav Roussy, M.D. Anderson Cancer Center, Sheba Medical Center, Holy Family Hospital, Nazareth, Israel, University College Cork, Univerzitetni klinicni center Maribor, Academisch Ziekenhuis Groningen, Technical University of Munich, Technion, Israel Institute of Technology, Vrije Universiteit Brussel, Cancer Patients Europe, University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- Michael Golatta, MD, Study director, University Hospital HeidelbergAndré Pfob, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266026
- Sponsor's protocol ID
- ThermoBreast
- Acronym
- ThermoBreast
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. An International, Multicenter, Prospective Development and Validation Trial.
- ClinicalTrials.gov ID
- NCT06266026
- Acronym / sponsor ID
- ThermoBreast / ThermoBreast
- Conditions
- Breast Cancer
- Keywords
- Artificial Intelligence, Thermography, breast imaging, breast diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28,000 participants (estimated)
- Lead sponsor
- ThermoMind Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Assuta Medical Centers Ltd., Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Institut Gustav Roussy, M.D. Anderson Cancer Center, Sheba Medical Center, Holy Family Hospital, Nazareth, Israel, University College Cork, Univerzitetni klinicni center Maribor, Academisch Ziekenhuis Groningen, Technical University of Munich, Technion, Israel Institute of Technology, Vrije Universiteit Brussel, Cancer Patients Europe, University Hospital Heidelberg
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Feb 2024 (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.
Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.
Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.
To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring.
Detailed description
This study is designed as a multicenter, prospective, blinded, three cohorts, diagnostic trial. Patients will be recruited at 11 centers in France, Germany, Ireland, Israel, Slovenia, Lithuania, and the US.
The primary objective is to compare the diagnostic performance of advanced image processing AI models to automatically predict breast malignancy based on thermograms and individual patient data collected during breast examination (ThermoBreast) with routine breast cancer screening and imaging.
The study population consists of women undergoing routine screening for breast cancer or diagnostic evaluation of suspicious breast masses. The study will recruit women into three cohorts: Screening cohort, High-Risk Screening, and Diagnostics cohort. Participants recruited for the study will be assigned to a dedicated cohort based on the reason of the visit.
There will be two visits for study participants, partially including study specific and routine procedures, who meet the inclusion criteria in the screening procedure.
The first trial visit (V1.1) will take place to provide the patient with detailed information on the study, its aims, the ThermoBreast procedure, and its risks. In- and exclusion criteria will be checked. Informed consent will be obtained. If the patient consents, the study specific ThermoBreast procedure (index test) and a study specific questionnaire regarding user experience will be performed. Moreover, the patient will undergo the routine first breast cancer screening round (screening cohort) or the routine first breast cancer diagnostics round (diagnostic cohort) according to national guidelines which serve as a reference test. In the screening cohort, the patient may undergo routine breast diagnostics following an irregular first screening round (V1.2) according to national guidelines.
The second trial visit (V2) serves as a follow-up visit for the reference test - no study specific interventions will be performed here. Patients will undergo routine breast cancer screening or diagnostics according to national guidelines which serve as a reference test. In the screening cohort, the patient may undergo routine breast diagnostics following an irregular second screening round (V2.2) according to national guidelines. No study specific interventions will be performed during this trial visit.
There will be no randomization within this study design. The findings of thermal screening will not be disclosed to patients and physicians, to avoid any anxiety or influence on the physicians' decision-making, as the proposed method is under study and development. The ThermoBreast system will only record the thermal imaging but will not automatically display any final assessment with respect to risk of breast cancer.
AI-based evaluation of dynamic breast thermography imaging (=ThermoBreast, index test) will serve as the outcome measure. The ThermoBreast evaluation will be performed independently of the routine breast diagnostic evaluation. Some baseline risk variables (e.g. patient age, hormonal status) may be included in the ThermoBreast evaluation. ThermoBreast will provide a risk score for invasive breast cancer on a per-patient basis (not per breast).
Routine breast diagnostics will serve as a reference test against which the ThermoBreast outcome will be compared. Depending on national guidelines and clinical scenarios, routine breast cancer diagnostics can consist of several routine procedures, including clinical examination, ultrasound, mammography, tomosynthesis, MRI, follow-up imaging, biopsy, surgical excision, and histopathologic evaluation. All procedures will be performed as indicated and specified by the respective, current national guidelines.
The AI-based evaluation will use state-of-the-art image analysis techniques. The algorithm will be trained on data acquired during the training phase of the trial. For the second 6 month validation phase of the trial, a data lock will ensure that outcomes with respect to the reference test (routine breast diagnostics) will not be available anymore for the team responsible for the ThermoBreast algorithm development.
A positive reference test is defined as histopathologic diagnosis of invasive breast cancer.
A negative reference test is defined as
- For the hypothesis without follow-up: a first study visit without biopsy indication (breast imaging BI-RADS 3,2 or 1), or a benign histopathologic evaluation.
- For the hypothesis with follow-up: two regular study visits (breast imaging BI-RADS 2 or 1), a regular follow-up imaging after an irregular screening/imaging finding (BI-RADS 3 followed by BI-RADS 2 or 1), or a benign histopathologic evaluation.
Analyses will be performed on a per-patient basis. In case of multiple breast masses per patient, the one with the highest risk of breast cancer or histopathological confirmed invasive breast cancer will be considered for the primary efficacy analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Screening cohort
- High-risk screening cohort
- Diagnostics cohort
Key exclusion criteria (6 listed)
- (High-risk) Screening and Diagnostics cohort
- Subjects who are pregnant or lactating
- Subjects who have undergone lumpectomy or mastectomy in the last 4 months at the time of study enrollment
- Subjects who have undergone cancer therapy (chemotherapy, start of hormonal therapy, radiotherapy, surgery) in the last 4 months at the time of study enrollment
- Subjects who have undergone a breast biopsy in the last 2 months at the time of study enrollment
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 |
|---|---|---|
| ThermoBreast - AI-based evaluation of dynamic breast thermography imagingAlso: ThermoMind Vision One DeviceIndex test: AI-based evaluation of dynamic breast thermography imaging (ThermoBreast). The ThermoBreast evaluation will be performed independently of the routine breast cancer diagnostic evaluation. Some baseline risk variables (e.g. patient age, hormonal status) may be included in the ThermoBreast evaluation. Reference test: Routine breast diagnostics will serve as a reference test against which the ThermoBreast outcome will be compared. Depending on national guidelines and clinical scenarios, routine breast cancer diagnostics can consist of several routine procedures, including clinical examination, ultrasound, mammography, tomosynthesis, MRI, follow-up imaging, biopsy, surgical excision, and histopathologic evaluation. All procedures will be performed as indicated and specified by the respective, current national guidelines. | Diagnostic test | – |
Primary outcome
Sensitivity (true-positive rate)
Time frame: up to 2 years of follow-up
As our primary outcome we will use true-positive ThermoBreast results, i.e. detected invasive breast cancer by ThermoBreast (=index test) compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging (=reference test). We will report this outcome as the true-positive rate (=TPR, rate of patients with non-detected invasive breast cancer by ThermoBreast compared to histopathologically confirmed invasive breast cancer during routine breast cancer screening/imaging) which is a commonly used and validated measure in diagnostic studies.
Specificity (true-negative rate)
Time frame: up to 2 years of follow-up
As a co-primary outcome we will measure the specificity of the ThermoBreast screening modality. The specificity will be defined as the rate of true-negative ThermoBreast results, i.e., the number of correctly identified absence of invasive breast cancer by ThermoBreast, when compared to the number of absence of histopathologically confirmed invasive breast cancer or regular follow-up imaging during routine breast cancer screening/imaging. This outcome will be reported as the true-negative rate (=TNR, rate of patients for whom ThermoBreast correctly identifies the absence of invasive breast cancer in alignment with the results from routine breast cancer screening/imaging).
20 secondary outcomes
Cancer detection rate
Time frame: up to 2 years of follow-up
Detection rate of ductal carcinoma in situ (DCIS)
Time frame: up to 2 years of follow-up
Detection rate of tumor category pT1
Time frame: up to 2 years of follow-up
Recall rate
Time frame: up to 2 years of follow-up
Sensitivity
Time frame: up to 2 years of follow-up
Specificity
Time frame: up to 2 years of follow-up
Positive-predictive value
Time frame: up to 2 years of follow-up
Negative-predictive value
Time frame: up to 2 years of follow-up
Diagnostic performance in the three trial cohorts
Time frame: up to 2 years of follow-up
Proportion of breast quadrant localization
Time frame: Screening visit
Proportion of correct histopathologic subtype identification
Time frame: up to 2 years of follow-up
Proportion of correct tumorbiologic subtype identification
Time frame: up to 2 years of follow-up
Proportion of correct axillary lymph node involvement identification
Time frame: up to 2 years of follow-up
Effect of hormonal status on diagnostic performance
Time frame: up to 2 years of follow-up
Effect of breast density on diagnostic performance
Time frame: up to 2 years of follow-up
Effect of ethnicity on diagnostic performance
Time frame: up to 2 years of follow-up
Timing of ThermoBreast
Time frame: up to 2 years of follow-up
Screening time
Time frame: Screening visit
Cost-effectiveness
Time frame: up to 2 years of follow-up
Lived Experience
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Related InfoLink provided by the sponsor.
- 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.
Michael Golatta, MD study director
University Hospital Heidelberg
André Pfob, MD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoBreast - AI-based evaluation of dynamic breast thermography imaging in people with Breast Cancer, run by ThermoMind Ltd. at 1 site in Germany.
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 12 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: looking for participants now, as of the sponsor's last update on 20 Feb 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hakan Yesilmen (+972 547833599, hakan@thermomind.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (true-positive rate) (time frame: up to 2 years of follow-up). The study lists 2 primary outcomes in all. 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 20 Feb 2024.