NCT Number: NCT06045572
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: [D2, approximately 60 days]
Identification of the lesion (Yes/No); Identification of vascular alterations (Yes/No).
Time frame: [D2, approximately 60 days]
Vascular imaging (Yes/No); Vascular asymmetry (Yes/No); Thermal signature / tumor coverage (Yes/No). Identification of vascular alterations (Yes/No).
Time frame: [D2, approximately 60 days]
Yes/No
Time frame: [D2, approximately 60 days]
Numerical (1 to 10)
Time frame: [D2, approximately 60 days]
Neoplastic, non-neoplastic and without alterations; Aggressiveness (Yes/No); Invasiveness (Yes/No); Presence of mutation (Yes/No); Gene expression: BRCA1/BRCA2, TP53, ATM, PTEN, STK11/LKB1 (Yes/No); Gene expression: S100P, NUP88 (2x, 3x, higher); Gene expression: ATP6V1C1 and TP6V1C2 (predominance of the C1/C2 isoform).
Time frame: [D2, approximately 60 days]
Imaging data will be rated using a Likert scale by the study evaluator/radiologists (unacceptable, poor, acceptable, good, excellent);
Time frame: [D2, approximately 60 days]
easy/moderate/complex
Time frame: [D2, approximately 60 days]
fast/acceptable/long
Time frame: [D2, approximately 60 days]
Y/N
Time frame: [D2, approximately 60 days]
Y/N
Time frame: [D2, approximately 60 days]
important/indifferent
Time frame: [D2, approximately 60 days]
discrete numerical and categorical Y/N
Time frame: [D2, approximately 60 days]
numerical, %
Time frame: [D2, approximately 60 days]
Calculation of adherence to treatment; Proportion of participants who withdrew consent; Proportion of participants who dropped out of treatment.
Time frame: [D1, approximately 01 day]
Gender (F/M), age (Years), weight (Kg), height (m);
Time frame: [D1, approximately 01 day]
Past pathological history; Hormonal activity: pregnancy, breastfeeding, menarche and puerperium; Anamnesis, health history and complaints.
Time frame: [D1, approximately 01 day]
Density of breast tissue; the size of the lesion; Degree of aggressiveness; BI-RADS classification.
Contact information is provided by the study sponsor or research team.
Paula GA Cabral, PhD
CONTACT
Savio B Souza, PhD
CONTACT
Galzu Institute of Research, Teaching, Science and Applied Technology
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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