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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Device: VTM examination and breast biopsy

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savio B Souza, PhD; Phone Number: 5522999857370; Email: saviobas@gmail.com
• Study Contact Backup: Name: Paula GA Cabral, PhD; Phone Number: 5522999857370; Email: pgacabral99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: women diagnosed with breast cancer before cancer treatment	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	[D2, approximately 60 days]
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).	[D2, approximately 60 days]
Frequency of identifying non-visible textures	Yes/No	[D2, approximately 60 days]
Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities:	Numerical (1 to 10)	[D2, approximately 60 days]
Frequency of sample changes detected by VTM	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).	[D2, approximately 60 days]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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);	[D2, approximately 60 days]
(ClinROs) Ease of use and functionality;	easy/moderate/complex	[D2, approximately 60 days]
(ClinROs) Image acquisition time;	fast/acceptable/long	[D2, approximately 60 days]
(PROs) Discomfort during the VTM exam;	Y/N	[D2, approximately 60 days]
(PROs) Pain during VTM exam;	Y/N	[D2, approximately 60 days]
(PROs) Importance of the VTM exam research to the participant;	important/indifferent	[D2, approximately 60 days]
Frequency of adverse events, unexpected adverse events, and serious adverse events (discrete numerical and categorical yes/no);	discrete numerical and categorical Y/N	[D2, approximately 60 days]
All-cause mortality rate during the study;	numerical, %	[D2, approximately 60 days]
Tolerability of the VTM exam;	Calculation of adherence to treatment; Proportion of participants who withdrew consent; Proportion of participants who dropped out of treatment.	[D2, approximately 60 days]
Demographic data analysis;	Gender (F/M), age (Years), weight (Kg), height (m);	[D1, approximately 01 day]
Demographic data analysis;	Past pathological history; Hormonal activity: pregnancy, breastfeeding, menarche and puerperium; Anamnesis, health history and complaints.	[D1, approximately 01 day]
Prospective data.	Density of breast tissue; the size of the lesion; Degree of aggressiveness; BI-RADS classification.	[D1, approximately 01 day]

Collaborators and Investigators

• Sponsor: Galzu Institute of Research, Teaching, Science and Applied Technology
• Collaborators: Hospital Santa Casa de Misericordia de Campos; Hospital Escola Alvaro Alvim; Universidade Estadual do Norte Fluminense (UENF)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IGZ-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No