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

NCT06045572 | Not Yet Recruiting

• 1 other identifier: IGZ-03
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• (ClinROs) Diagnostic image quality by VTM in pathological changes of the breast;

  [D2, approximately 60 days]

• (ClinROs) Ease of use and functionality;

  [D2, approximately 60 days]

• (ClinROs) Image acquisition time;

  [D2, approximately 60 days]

• (PROs) Discomfort during the VTM exam;

  [D2, approximately 60 days]

• (PROs) Pain during VTM exam;

  [D2, approximately 60 days]

Study Arms (1)

women diagnosed with breast cancer before cancer treatment

EXPERIMENTAL

Device: VTM examination and breast biopsy

Interventions

VTM examination and breast biopsy DEVICE

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.

women diagnosed with breast cancer before cancer treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Central Study Contacts

Paula GA Cabral, PhD

CONTACT

5522999857370; pgacabral99@gmail.com

Savio B Souza, PhD

CONTACT

5522999857370; saviobas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share