Clinical trial NCT06045572: Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer
Official title: Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Galzu Institute of Research, Teaching, Science and Applied Technology
Sponsor class: OTHER
Collaborators: name: Hospital Santa Casa de Misericordia de Campos
name: Hospital Escola Alvaro Alvim
name: Universidade Estadual do Norte Fluminense (UENF)
First posted: 2023-09-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pivotal, prospective, controlled study (comparison with genetic tests, histopathological / immunohistochemical analysis) to evaluate the safety and performance of VTM as a diagnostic test in breast cancer.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Breast cancer control has been one of the priorities on the agenda of the National Health Policy in Brazil. Thus, the Ministry of Health, through the publication "Guidelines for the Early Detection of Breast Cancer in Brazil", recommends the identification of the disease in its early stages through early detection strategies. It is estimated that there will be 66,280 new cases of breast cancer for each year of the three-year period 2020-2022 in Brazil and Population-Based Cancer Registries (RCBP), Hospital Cancer Registries (RHC) and information on Mortality are essential requirements for national and regional programs for cancer control, in addition to guiding the research agenda.

According to the National Cancer Institute (INCA), the benefit of screening mammography is in early identification, allowing for less aggressive treatment.

VTM is a functional method that demonstrates the metabolic intensity in real time, through images in the colors of the visible spectrum without using ionizing energy or contrast. It expresses metabolic alterations before anatomical transformations. It is a method without radiation, contrast, pain or contact, and can be used without limiting the exposure time.

Eligibility criteria: Inclusion Criteria:

Women ≥18 years old; Women with breast cancer before oncological treatment; Voluntary signature of the Free and Informed Consent Term.

Exclusion Criteria:

Pregnant or lactating women; Patients already included in other clinical trials; Patients who are undergoing radiotherapy, chemotherapy or post-cancer surgery treatment; Patients who need urgent or emergency care; Patients with fever or other illness that affects the integrity of the skin; Any clinically significant medical condition or medical history that, in the opinion of the investigator, may discourage participation in the study.

Primary outcomes:
measure: Concordance of the diagnosis of abnormality during the VTM exam in relation to the standard exam (mammography);
timeFrame: [D2, approximately 60 days]
measure: Frequency of non-visible vascular identification:
timeFrame: [D2, approximately 60 days]
measure: Frequency of identifying non-visible textures
timeFrame: [D2, approximately 60 days]
measure: Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities:
timeFrame: [D2, approximately 60 days]
measure: Frequency of sample changes detected by VTM
timeFrame: [D2, approximately 60 days]
Secondary outcomes:
measure: (ClinROs) Diagnostic image quality by VTM in pathological changes of the breast;
timeFrame: [D2, approximately 60 days]
measure: (ClinROs) Ease of use and functionality;
timeFrame: [D2, approximately 60 days]
measure: (ClinROs) Image acquisition time;
timeFrame: [D2, approximately 60 days]
measure: (PROs) Discomfort during the VTM exam;
timeFrame: [D2, approximately 60 days]
measure: (PROs) Pain during VTM exam;
timeFrame: [D2, approximately 60 days]
measure: (PROs) Importance of the VTM exam research to the participant;
timeFrame: [D2, approximately 60 days]
measure: Frequency of adverse events, unexpected adverse events, and serious adverse events (discrete numerical and categorical yes/no);
timeFrame: [D2, approximately 60 days]
measure: All-cause mortality rate during the study;
timeFrame: [D2, approximately 60 days]
measure: Tolerability of the VTM exam;
timeFrame: [D2, approximately 60 days]
measure: Demographic data analysis;
timeFrame: [D1, approximately 01 day]
measure: Demographic data analysis;
timeFrame: [D1, approximately 01 day]
measure: Prospective data.
timeFrame: [D1, approximately 01 day]
Other outcomes:
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Study officials:
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