When we talk about early identification, we are talking about an ALREADY EXISTING INJURY, triggering a change in the patient's quality of life and a projection of future costs for the health system.
INNOVATIVE ASPECT: While screening mammography identifies an existing lesion, VTM could: Make an early diagnosis before the formation of a visible or palpable tumor mass; Check the metabolic activity in suspicious lesions identified by other diagnostic methods; Demarcate tumor range and tumor similarity from a distance in breast cancer.
Regarding the Risk x Benefit:There are no medications incorporated, associated or administered by the equipment; There is no ionizing radiation incorporated or delivered by the equipment; There are no contraindications for the use of the equipment by the patient (Non-ionizing infrared radiation, without contrast or contact); Audience destined to operate the equipment: Physician / Radiologist with training Therefore, the research in question is of great relevance for such a debilitating health problem for the patient and for the health system.
None
None
Single group
VTM examination and breast biopsy
DeviceVTM examination performed by a radiologist, at the MART (Metabolic Activity in Real-Time) station, using the SaMD Mart 2.0, according to the inspection protocol to identify breast alterations and/or suspicious images to be biopsied for validation by genetic tests and histology / immunohistochemistry.
Concordance of the diagnosis of abnormality during the VTM exam in relation to the standard exam (mammography);
Identification of the lesion (Yes/No); Identification of vascular alterations (Yes/No).
Frequency of non-visible vascular identification:
Vascular imaging (Yes/No); Vascular asymmetry (Yes/No); Thermal signature / tumor coverage (Yes/No). Identification of vascular alterations (Yes/No).
Frequency of identifying non-visible textures
Yes/No
Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities:
Numerical (1 to 10)
(ClinROs) Diagnostic image quality by VTM in pathological changes of the breast;
Imaging data will be rated using a Likert scale by the study evaluator/radiologists (unacceptable, poor, acceptable, good, excellent);
(ClinROs) Ease of use and functionality;
easy/moderate/complex
(ClinROs) Image acquisition time;
fast/acceptable/long
(PROs) Discomfort during the VTM exam;
Y/N
Click on the lead sponsor to view all of their trials.
Galzu Institute of Research, Teaching, Science and Applied Technology
Lead sponsor
Hospital Santa Casa de Misericordia de Campos
Collaborator
Hospital Escola Alvaro Alvim
Collaborator
Universidade Estadual do Norte Fluminense (UENF)
Collaborator
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