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

NCT06045572 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Santa Casa de Misericordia de Campos

    collaborator UNKNOWN

  • Hospital Escola Alvaro Alvim

    collaborator UNKNOWN

  • Universidade Estadual do Norte Fluminense (UENF)

    collaborator UNKNOWN

  • Galzu Institute of Research, Teaching, Science and Applied Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-06-01
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045572 on ClinicalTrials.gov