Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство VTM examination and breast biopsy
  VTM 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.

Первичные конечные точки

• Concordance of the diagnosis of abnormality during the VTM exam in relation to the standard exam (mammography); [Срок оценки: [D2, approximately 60 days]]
• Frequency of non-visible vascular identification: [Срок оценки: [D2, approximately 60 days]]
• Frequency of identifying non-visible textures [Срок оценки: [D2, approximately 60 days]]
• Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities: [Срок оценки: [D2, approximately 60 days]]
• Frequency of sample changes detected by VTM [Срок оценки: [D2, approximately 60 days]]

Вторичные конечные точки (12)

• (ClinROs) Diagnostic image quality by VTM in pathological changes of the breast; [Срок оценки: [D2, approximately 60 days]]
• (ClinROs) Ease of use and functionality; [Срок оценки: [D2, approximately 60 days]]
• (ClinROs) Image acquisition time; [Срок оценки: [D2, approximately 60 days]]
• (PROs) Discomfort during the VTM exam; [Срок оценки: [D2, approximately 60 days]]
• (PROs) Pain during VTM exam; [Срок оценки: [D2, approximately 60 days]]
• (PROs) Importance of the VTM exam research to the participant; [Срок оценки: [D2, approximately 60 days]]
• Frequency of adverse events, unexpected adverse events, and serious adverse events (discrete numerical and categorical yes/no); [Срок оценки: [D2, approximately 60 days]]
• All-cause mortality rate during the study; [Срок оценки: [D2, approximately 60 days]]
• Tolerability of the VTM exam; [Срок оценки: [D2, approximately 60 days]]
• Demographic data analysis; [Срок оценки: [D1, approximately 01 day]]
• Demographic data analysis; [Срок оценки: [D1, approximately 01 day]]
• Prospective data. [Срок оценки: [D1, approximately 01 day]]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06045572 · IGZ-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗