Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sclerosis

Scleroderma, Systemic

Scleroderma, Diffuse

Raynaud Disease

Neoplastic Processes

Connective Tissue Diseases

Skin Diseases

Vascular Diseases

Livedoid Vasculopathy

Thrombosis

Embolism

Embolism and Thrombosis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Skin Diseases, Vascular

Systemic Scleroderma

Acute Graft Versus Host Disease

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

All Drugs and Chemicals

Alprostadil

300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration

Placebo

Barbara Troupin, MD, MBA

The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Immune System Diseases

Hypersensitivity

Device

Rubens F Mendrone

Luciana MB Ferrara

Florentino de Araujo Cardoso Filho, MD, PhD

Luciana Ferrara

The LINDA thermal device consists of a thermal camera attachable to a cell phone and an application for connection with an artificial intelligence program based on a convolutional neural network for classification of thermographic breast images. The system is previously fed with thermographic images of the breast and their respective results/diagnostics. The images are processed in an automated way and return a percentage of chance of having a pathological pattern.

The LINDA thermal device consists of a thermal camera attachable to a cell phone and an application for connection with an artificial intelligence program based on a convolutional neural network for classification of thermographic breast images. The system is previously fed with thermographic images of the breast and their respective results/diagnostics. The images are processed in an automated way and return a percentage of chance of having a pathological pattern.

nfrared imaging (thermography) was approved as an auxiliary imaging modality for mammography by the Food and Drug Administration (FDA) in 1982. Thermography is a non-invasive, non-contact method without ionizing radiation, which is why its use can be prolonged and repeated. This technique allows for an evaluation of the functionality of the structures, which is why it is considered a physiological test and records the variation in the surface temperature of the human body based on the infrared radiation emitted by the surface of that body. It is capable of detecting tumor lesions since cancer cells generate heat due to the release of nitric oxide in the blood, causing changes in microcirculation, vasodilation, neo-angiogenesis and increased metabolic activity of cancer cells. Thus, in the initial stage of breast cancer, when it has not yet caused anatomical changes, there will be physiological changes that will lead to an increase in blood flow and metabolic activity. This increase induces a temperature rise in the area which will then be detected by thermography.

Study To Evaluate The Sensitivity Of The Linda Thermal Device

Study To Evaluate The Sensitivity Of The Linda Thermal Device In Relation To Mammography In The Detection Of Suspected Breast Neoplasia

It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

The primary objective of the study is to assess the thermal sensitivity of the LINDA device in detecting suspected breast cancer compared to mammography.

Termo Health Tecnologia Ltda

Azidus Brasil

Breast Neoplasms

Breast Diseases

All participants will be examined with

1. Dynamic infrared thermography (FLIR ThermaCAM P-65)
2. Mammography, clinical examination and if necessary breast tissue biopsy to diagnose breast cancer.

Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.

FLIR ThermaCAM P-65

Åshild O. Miland, PhD

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected for assessment after mammography screening were invited to dynamic infrared thermography before clinical mammography and further examination.

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics.

Dynamic infrared thermography (DIRT) is an imagine procedure offering a non-invasive, painless examination without risk of radiation. Dynamic infrared thermography does not provide information on the morphological characteristics of the breast, rather it provides functional information on thermal and vascular conditions of the tissue (Fitzgerald, 2012).

During the study period from April 2009 until June 2012, a total of 168 women aged 50-70 years who were recalled for assessment after positive mammography screening were offered dynamic infrared thermography before further tests (clinical mammography, clinical examination and if necessary breast tissue biopsy).

Radiographers at the Breast Diagnostic Center (BDS) at University Hospital North Norway collected information about parity, menopausal status, use of hormone therapy and size of bra.

The same radiographers also carried out all the dynamic infrared thermography examinations. PI Åshild O. Miland and Professor James B. Mercer interpreted the thermograms and entered the data into the thermography database. Both were blinded for further assessments (mammography, clinical examination and biopsy) and non of them talked to any of the participants after the examination.

The health professionals who were responsible for the women during mammography, clinical examination and biopsy were blinded for the results from the infrared digital thermography examination. They were not allowed to ask the women about the infrared digital thermography examination.

The three radiologists at BDS made the interpretation of the mammographies and entered data into the digital patient journal and to the mammography database at The Norwegian Cancer Registry. One of the radiologist took, when necessary, breast biopsies. A breast surgeons were responsible for the clinical breast examination. Pathologists verified the histology.

Breast radiologist Jan Ole Frantzen and researcher Merethe Kumle, MD, PhD collected information about breast cancer results from the digital patient journal and Roentgen information system (RIS) and entered it into a separate mammography database.

The thermography database and the mammography database was still not merged at the time of registration in ClinicalTrials.gov (March 2015).

Dynamic Infrared Thermography in Breast Cancer Diagnostics

Dynamic Infrared Thermography in Breast Cancer Diagnostics. A Diagnostic Accuracy Study Comparing Dynamic Infrared Thermography Against Mammography (Reference Standard)

This is a small Diagnostic Accuracy Study, the investigators will decide upon data sharing when they have finished the statistical analysis. If someone is interested in the data, please contact the investigators.

Can thermography distinguish benign from malign tumours in breast cancer diagnostics. The gold standard is breast biopsy pathology.

The outcome is measured as number of subjects with pathological diagnosis of cancer.

University Hospital of North Norway

The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.

Sentinel BreastScan II

Haitham Elsamaloty

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.

FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II \[SBS II\]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.

Male or Female, over the age of 18 years.

Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.

To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol \[ Th 1 thru 5 \] to biopsy results predicated on standard breast imaging criteria \[ BIRADS analytical protocol, B1 thru B5 \]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis \[ Th1 thru 5 \] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy \[ BIRADS 3 thru 5 \] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.

University of Toledo Health Science Campus

First Sense Medical, LLC

Pharmaceutical Solutions

Women who came in for a breast mammography between ages 30 and 80 years were invited to take part in the study. All the women included in the study underwent breast cancer screening first by Thermalytix, the AI-based thermal imaging test, followed by mammography.

Thermalytix is an Artificial intelligence based automated breast screening solution that analyzes thermal distribution on the breast to generate a breast health score automatically. Thermal imaging was performed by a trained technician to capture thermal images of the participant in five views. These thermal images were uploaded to Thermalytix software on the cloud where it was automatically analyzed by AI-based Thermalytix computer-aided detection (CADe) engine. This CADe engine analyzes uploaded thermal images and outputs an interpretation report for each participant with quantitative scores corresponding to computed probability of malignancy based on the structural, vascular, areolar, thermal properties of the observed abnormality. Thermalytix also generates annotated images with markings of abnormal regions and an overall Thermalytix score suggesting likelihood of breast malignancy. The locked AI model Thermalytix algorithm version 3, dated December 2018 was used for the analysis.

Thermalytix

Richa Bansal, MD

The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.

While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is a novel automated breast cancer screening solution that uses artificial intelligence (AI) over thermal images to detect and localise breast cancer lesions in women. In this study the performance of Thermalytix over mammography is evaluated in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography, and participants who were reported as positive on either test were recommended for further investigations. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated across age-groups, menopausal status, and breast densities against the current standard-of-care diagnostic modalities.

The participant eligibility is based on self-representation of gender identity

A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers

A Prospective Study to Evaluate the Effectiveness of Thermalytix (AI-based Thermographic Solution Developed by Niramai) for Breast Cancer Screening as Compared to Standard Screening Modalities for Breast Cancer

The study protocol and clinical study report will be made available to investigators from academic institutions for non-commercial use and whose proposed use of the data has been approved by an independent review committee. The individual participant data would be shared for meta-analysis.

To assess the clinical performance of Thermalytix as compared to standard screening modalities

To assess the influence of patient characteristics, such as age, menopausal status, breast density on the diagnostic accuracy of Thermalytix. The patient characteristics will be collected through a questionnaire.

Max Healthcare Insititute Limited

Niramai Health Analytix Private Limited

Women aged 18-49 who had breast ultrasound performed with a result of BI-RADS 4b, 4c or 5. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to breast ultrasound. The planned number of participants in the group: n=700 people.

Women aged 50 and above who had mammography and/or breast ultrasound performed (both examinations are obligatory, i.e. if the subject was recruited based on mammography, then ultrasound must be performed and vice-versa). Women were recruited if they had a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or BI-RADS 4a, 4b, 4c or 5 on ultrasound. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to the aforementioned techniques. The planned number of participants in the group: n=2100 people.

Subgroup C1 (n=100 people): women aged 18-49 years, who underwent breast ultrasound with a result of BI-RADS 1 or 2.

Sub-group C2 (n=100 people): women aged 50 and above, who had mammography or breast ultrasound performed; with a result of BI-RADS 1 or 2 (both examinations are obligatory, i.e. if the subject was recruited based on mammography, then ultrasound must be performed and vice-versa).

Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to the aforementioned techniques.

A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.

Contact thermographic breast examination device

Paweł Basta, MD PhD

The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.

The study is a multicentre, observational, cross-sectional, open and monitored trial involving approx. 3000 females who will be subject to an examination using liquid crystal contact thermography device as a complementary tool to standard diagnostic imaging procedures of the breast glands. The study is conducted in specialist outpatient clinics. Patients are eligible to participate in the study upon signing the informed consent form. There is no follow up after the thermographic examination.

The study will comprise of a single registration of thermographic images of the breasts which will be subjected to automatic and expert analysis by radiologists.

Primary objective of the study is to determine and compare the diagnostic efficacy of breast thermography using a medical device based on liquid crystal contact thermography to standard of care.

The subjects were divided into three groups based on age and Breast Imaging Reporting and Data System (BI-RADS). Thermography was performed as a complementary modality to standard of care. In group A, the investigators recruited women aged 18-49, who has a breast ultrasound performed and a result of BI-RADS 4b, 4c or 5. In group B, the investigators recruited women over 50 years of age with either a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or BI-RADS 4a, 4b, 4c or 5 on ultrasound. If a positive result was present on one of these examinations, the other examination needed to be performed. Lastly, in group C, the investigators recruited women aged 18 and above with a BI-RADS score of 1 or 2 on mammography and/or breast ultrasound.

Predicted duration of the study is approximately 24 months.

Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts

Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer

The outcome is measured as number of subjects with pathological diagnosis of cancer. Subjects will be analysed based on age, 18-49 and women over 50.

Comparison of the field below the Receiver Operating Characteristic (ROC) curve (C statistic) and sensitivity and specificity between the age and recruitment groups as well as between the manual algorithm and automatic interpretation algorithm will take place with the use of Wald and McNemar tests.

Values P \< 0.05 will be recognised as statistically significant.

National Center for Research and Development, Poland

Braster S.A.

Bioscience, S.A.

Jagiellonian University

Ass. Prof. Department of Gynaecology and Oncology Jagiellonian University, Medical College

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.

ThermoBreast - AI-based evaluation of dynamic breast thermography imaging

Hakan Yesilmen

Larisa Adamyan, PhD

André Pfob, MD

Michael Golatta, MD

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.

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

ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography.

ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. An International, Multicenter, Prospective Development and Validation Trial.

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.

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).

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)

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.

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.

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)

To evaluate the sensitivity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)

To evaluate the specificity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)

To evaluate the positive-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)

To evaluate the negative-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)

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

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.

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.

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.

The compare the diagnostic performance of ThermoBreast to axillary ultrasound in the detection of axillary lymph node metastasis in terms of sensitivity and specificity

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

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.

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

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

To estimate the possibility to reduce the screening time by evaluating the effect of screening duration on the performance of ThermoBreast

To evaluate the cost-effectiveness of ThermoBreast for breast cancer screening and diagnosis. A cost per QALY analysis will be conducted.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Study To Evaluate The Sensitivity Of The Linda Thermal Device	NCT05009277	Device Thermography Mammography	Device	40 Years - 69 Years	Azidus Brasil
Dynamic Infrared Thermography in Breast Cancer Diagnostics	NCT02829021	Breast Cancer	FLIR ThermaCAM ...	50 Years - 69 Years	University Hospital of North Norway
Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.	NCT03271853	Breast Neoplasm... Cancer, Breast Thermography	Sentinel Breast...	18 Years -	First Sense Medical, LLC
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers	NCT04688086	Breast Cancer Early Detection...	Thermalytix	18 Years - 80 Years	Niramai Health Analytix Private Limited
Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts	NCT03735550	Breast Cancer	Contact thermog...	18 Years -	Jagiellonian University
Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts	NCT03735550	Breast Cancer	Contact thermog...	18 Years -	Jagiellonian University
ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography.	NCT06266026	Breast Cancer	ThermoBreast - ...	18 Years -	ThermoMind Ltd.
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers	NCT04688086	Breast Cancer Early Detection...	Thermalytix	18 Years - 80 Years	Niramai Health Analytix Private Limited
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Spots Global Cancer Trial Database for thermography

Every month we try and update this database with for thermography cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.