Collaborator:
Assuta Medical Centers Ltd., Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Institut Gustav Roussy, M.D. Anderson Cancer Center, Sheba Medical Center, The Holy Family Hospital Nazareth, University College Cork, Univerzitetni klinicni center
Studienleiter
Michael Golatta, MD Study Director University Hospital Heidelberg André Pfob, MD Principal Investigator University Hospital Heidelberg
1. 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.
2. 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).
Secondary outcome:
1. Cancer detection rate (Time Frame - up to 2 years of follow-up): 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)
2. Detection rate of ductal carcinoma in situ (DCIS) (Time Frame - up to 2 years of follow-up): 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.
3. Detection rate of tumor category pT1 (Time Frame - up to 2 years of follow-up): 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.
4. Recall rate (Time Frame - up to 2 years of follow-up): 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)
5. Sensitivity (Time Frame - up to 2 years of follow-up): To evaluate the sensitivity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
6. Specificity (Time Frame - up to 2 years of follow-up): To evaluate the specificity of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
7. Positive-predictive value (Time Frame - up to 2 years of follow-up): To evaluate the positive-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
8. Negative-predictive value (Time Frame - up to 2 years of follow-up): To evaluate the negative-predictive value of ThermoBreast and compare it with other standard breast cancer screening and diagnostic modalities (ultrasound, mammography, MRI)
9. Diagnostic performance in the three trial cohorts (Time Frame - up to 2 years of follow-up): 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
10. Proportion of breast quadrant localization (Time Frame - Screening visit): 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.
11. Proportion of correct histopathologic subtype identification (Time Frame - up to 2 years of follow-up): 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.
12. Proportion of correct tumorbiologic subtype identification (Time Frame - up to 2 years of follow-up): 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.
13. Proportion of correct axillary lymph node involvement identification (Time Frame - up to 2 years of follow-up): The compare the diagnostic performance of ThermoBreast to axillary ultrasound in the detection of axillary lymph node metastasis in terms of sensitivity and specificity
14. Effect of hormonal status on diagnostic performance (Time Frame - up to 2 years of follow-up): 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
15. Effect of breast density on diagnostic performance (Time Frame - up to 2 years of follow-up): 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.
16. Effect of ethnicity on diagnostic performance (Time Frame - up to 2 years of follow-up): 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
17. Timing of ThermoBreast (Time Frame - up to 2 years of follow-up): 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
18. Screening time (Time Frame - Screening visit): To estimate the possibility to reduce the screening time by evaluating the effect of screening duration on the performance of ThermoBreast
19. Cost-effectiveness (Time Frame - up to 2 years of follow-up): To evaluate the cost-effectiveness of ThermoBreast for breast cancer screening and diagnosis. A cost per QALY analysis will be conducted.
20. Lived Experience (Time Frame - Screening visit): 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.
ThermoBreast - AI-based evaluation of dynamic breast thermography imaging (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.
Quelle: ClinicalTrials.gov
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