Breast Cancer FemaleNCT06045572
Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer
A study testing VTM examination and breast biopsy in people with Breast Cancer Female, run by Galzu Institute of Research, Teaching, Science and Applied Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- VTM examination and breast biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ≥18 years old; Women with breast cancer before oncological treatment; Voluntary signature of the Free and Informed Consent Term.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- VTM examination and breast biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTM examination and breast biopsyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| women diagnosed with breast cancer before cancer treatment | Experimental | Not described Receives: Device: VTM examination and breast biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: [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).
Measured: [D2, approximately 60 days]
Frequency of identifying non-visible textures
Yes/No
Measured: [D2, approximately 60 days]
Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities:
Numerical (1 to 10)
Measured: [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).
Measured: [D2, approximately 60 days]
Secondary outcomes (12)
(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);
Measured: [D2, approximately 60 days]
(ClinROs) Ease of use and functionality;
easy/moderate/complex
Measured: [D2, approximately 60 days]
(ClinROs) Image acquisition time;
fast/acceptable/long
Measured: [D2, approximately 60 days]
(PROs) Discomfort during the VTM exam;
Y/N
Measured: [D2, approximately 60 days]
(PROs) Pain during VTM exam;
Y/N
Measured: [D2, approximately 60 days]
(PROs) Importance of the VTM exam research to the participant;
important/indifferent
Measured: [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
Measured: [D2, approximately 60 days]
All-cause mortality rate during the study;
numerical, %
Measured: [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.
Measured: [D2, approximately 60 days]
Demographic data analysis;
Gender (F/M), age (Years), weight (Kg), height (m);
Measured: [D1, approximately 01 day]
Demographic data analysis;
Past pathological history; Hormonal activity: pregnancy, breastfeeding, menarche and puerperium; Anamnesis, health history and complaints.
Measured: [D1, approximately 01 day]
Prospective data.
Density of breast tissue; the size of the lesion; Degree of aggressiveness; BI-RADS classification.
Measured: [D1, approximately 01 day]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galzu Institute of Research, Teaching, Science and Applied Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Santa Casa de Misericordia de Campos, Hospital Escola Alvaro Alvim, Universidade Estadual do Norte Fluminense (UENF)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045572
- Sponsor's protocol ID
- IGZ-03
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer
- ClinicalTrials.gov ID
- NCT06045572
- Acronym / sponsor ID
- IGZ-03
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Galzu Institute of Research, Teaching, Science and Applied TechnologyUniversity, hospital or other
- Collaborators
- Hospital Santa Casa de Misericordia de Campos, Hospital Escola Alvaro Alvim, Universidade Estadual do Norte Fluminense (UENF)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| women diagnosed with breast cancer before cancer treatment | Experimental | Device: VTM examination and breast biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women ≥18 years old; Women with breast cancer before oncological treatment; Voluntary signature of the Free and Informed Consent Term.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTM examination and breast biopsyVTM 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. | Device | women diagnosed with breast cancer before cancer treatment |
Primary outcome
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).
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).
Frequency of identifying non-visible textures
Time frame: [D2, approximately 60 days]
Yes/No
Frequency of thermal discrepancy in nearby pixels in areas suspected of non-visible abnormalities:
Time frame: [D2, approximately 60 days]
Numerical (1 to 10)
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).
12 secondary outcomes
(ClinROs) Diagnostic image quality by VTM in pathological changes of the breast;
Time frame: [D2, approximately 60 days]
(ClinROs) Ease of use and functionality;
Time frame: [D2, approximately 60 days]
(ClinROs) Image acquisition time;
Time frame: [D2, approximately 60 days]
(PROs) Discomfort during the VTM exam;
Time frame: [D2, approximately 60 days]
(PROs) Pain during VTM exam;
Time frame: [D2, approximately 60 days]
(PROs) Importance of the VTM exam research to the participant;
Time frame: [D2, approximately 60 days]
Frequency of adverse events, unexpected adverse events, and serious adverse events (discrete numerical and categorical yes/no);
Time frame: [D2, approximately 60 days]
All-cause mortality rate during the study;
Time frame: [D2, approximately 60 days]
Tolerability of the VTM exam;
Time frame: [D2, approximately 60 days]
Demographic data analysis;
Time frame: [D1, approximately 01 day]
Demographic data analysis;
Time frame: [D1, approximately 01 day]
Prospective data.
Time frame: [D1, approximately 01 day]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VTM examination and breast biopsy in people with Breast Cancer Female, run by Galzu Institute of Research, Teaching, Science and Applied Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula GA Cabral, PhD (5522999857370, pgacabral99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of the diagnosis of abnormality during the VTM exam in relation to the standard exam (mammography); (time frame: [D2, approximately 60 days]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.