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

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ClinicalTrials.gov Identifier: NCT06045572
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : February 22, 2024
Sponsor:
Collaborators:
Hospital Santa Casa de Misericordia de Campos
Hospital Escola Alvaro Alvim
Universidade Estadual do Norte Fluminense (UENF)
Information provided by (Responsible Party):
Galzu Institute of Research, Teaching, Science and Applied Technology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Female Device: VTM examination and breast biopsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Concordance of the diagnosis of abnormality during the VTM exam in relation to the standard exam (mammography); [ Time Frame: [D2, approximately 60 days] ]
    Identification of the lesion (Yes/No); Identification of vascular alterations (Yes/No).

  2. Frequency of non-visible vascular identification: [ 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).

  3. Frequency of identifying non-visible textures [ Time Frame: [D2, approximately 60 days] ]
    Yes/No

  4. Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities: [ Time Frame: [D2, approximately 60 days] ]
    Numerical (1 to 10)

  5. Frequency of sample changes detected by VTM [ 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).


Secondary Outcome Measures :
  1. (ClinROs) Diagnostic image quality by VTM in pathological changes of the breast; [ 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);

  2. (ClinROs) Ease of use and functionality; [ Time Frame: [D2, approximately 60 days] ]
    easy/moderate/complex

  3. (ClinROs) Image acquisition time; [ Time Frame: [D2, approximately 60 days] ]
    fast/acceptable/long

  4. (PROs) Discomfort during the VTM exam; [ Time Frame: [D2, approximately 60 days] ]
    Y/N

  5. (PROs) Pain during VTM exam; [ Time Frame: [D2, approximately 60 days] ]
    Y/N

  6. (PROs) Importance of the VTM exam research to the participant; [ Time Frame: [D2, approximately 60 days] ]
    important/indifferent

  7. Frequency of adverse events, unexpected adverse events, and serious adverse events (discrete numerical and categorical yes/no); [ Time Frame: [D2, approximately 60 days] ]
    discrete numerical and categorical Y/N

  8. All-cause mortality rate during the study; [ Time Frame: [D2, approximately 60 days] ]
    numerical, %

  9. Tolerability of the VTM exam; [ 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.

  10. Demographic data analysis; [ Time Frame: [D1, approximately 01 day] ]
    Gender (F/M), age (Years), weight (Kg), height (m);

  11. Demographic data analysis; [ Time Frame: [D1, approximately 01 day] ]
    Past pathological history; Hormonal activity: pregnancy, breastfeeding, menarche and puerperium; Anamnesis, health history and complaints.

  12. Prospective data. [ Time Frame: [D1, approximately 01 day] ]
    Density of breast tissue; the size of the lesion; Degree of aggressiveness; BI-RADS classification.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045572


Contacts
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Contact: Paula GA Cabral, PhD 5522999857370 pgacabral99@gmail.com
Contact: Savio B Souza, PhD 5522999857370 saviobas@gmail.com

Sponsors and Collaborators
Galzu Institute of Research, Teaching, Science and Applied Technology
Hospital Santa Casa de Misericordia de Campos
Hospital Escola Alvaro Alvim
Universidade Estadual do Norte Fluminense (UENF)
More Information
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Responsible Party: Galzu Institute of Research, Teaching, Science and Applied Technology
ClinicalTrials.gov Identifier: NCT06045572    
Other Study ID Numbers: IGZ-03
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases