Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266026
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-18
Brief Title:
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography
Sponsor:
ThermoMind Ltd
Organization:
ThermoMind Ltd
Study Overview
Official Title:
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography An International Multicenter Prospective Development and Validation Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ThermoBreast
Brief 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 Standard breast cancer diagnostic methods such as mammography ultrasound and MRI have limitations such as ionizing radiation high false-positive rates andor 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 patients 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
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 patients 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 V11 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 V12 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 V22 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 eg 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 32 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 screeningimaging 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
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 V11 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 V12 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 V22 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 eg 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 32 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 screeningimaging 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None