Breast CancerAR4SLNNCT07696754
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
A study testing Augmented-reality ICG fluorescence second-look imaging in people with Breast Cancer and Breast Neoplasms, run by Ss. Cyril and Methodius University of Skopje at 1 site in North Macedonia.
Trial summary
This prospective study will enroll up to 200 patients whose clinical team has already planned an axillary lymph node dissection for breast cancer. After the surgeon completes the planned dissection and declares that no further tissue was intended for removal, a wearable augmented-reality/virtual-reality (AR/VR) system… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Sentinel Lymph Node
- What is being tested?
- Augmented-reality ICG fluorescence second-look imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- Nov 2026to Nov 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven breast cancer
- Age 18 years or older
- Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection
- Provides written informed consent
Who cannot join
- Pregnancy
- Neoadjuvant chemotherapy
- Prior breast surgery
- Iodine or seafood allergy
- Indocyanine green (ICG) allergy
- Declines or is unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
North Macedonia1 site
University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM
Skopje, 1000
Borislav Kondov, MD, +38972539003, borislav.kondov@medf.ukim.edu.mk
About this study
Official title: Prospective Evaluation of Augmented-Reality ICG Fluorescence Second-Look After Axillary Lymph Node Dissection in Breast Cancer
This prospective study will enroll up to 200 patients whose clinical team has already planned an axillary lymph node dissection for breast cancer. After the surgeon completes the planned dissection and declares that no further tissue was intended for removal, a wearable augmented-reality/virtual-reality (AR/VR) system will show indocyanine-green (ICG) near-infrared fluorescence during a brief second look at the exposed surgical field. The surgeon may remove an additional fluorescent focus only after inspection under normal light and only when removal is safe and clinically appropriate. Each additional specimen will be labeled separately and examined by pathology.
The study measures the proportion of patients with an additional tumor-positive lymph node found at second look, whether such nodes change the pathological nodal category, operating time, and adverse events. The first 50 consecutive participants will form a planned descriptive device-feasibility analysis; all 200 participants will contribute to the full-cohort clinical analysis. The study does not assume that finding an additional node improves recurrence or survival.
Read the detailed description
This is a prospective, single-center, single-arm study of 200 unique participants undergoing breast cancer surgery with axillary lymph node dissection independently indicated by the clinical team. Earlier observations from an internal, unregistered protocol are not included in this study population. The first 50 consecutive enrolled participants form a prespecified descriptive device-feasibility subset; they remain part of the full 200-patient cohort and are not a separate arm.
Before AR/VR imaging, the operating surgeon records the indication and extent of the planned axillary dissection and declares that the standard procedure and inspection are complete. A brief ICG near-infrared fluorescence second look is then performed with the wearable system within the already exposed operative field. Each additional fluorescent focus receives a unique identifier, anatomic location, image or video reference when available, and a record of whether it was visible or palpable under standard lighting. The surgeon reassesses the focus under standard lighting and removes it only when safe and clinically appropriate. Each removed focus is submitted separately for pathology. Negative scans, foci left in place, interrupted scans, device failures, and added operating time are recorded.
The primary outcome remains the patient-level rate of pathology-confirmed clinically significant events (CSE) already defined in this record: at least one additional fluorescent focus not planned for removal before the second look, removed after standard-light reassessment, and confirmed to be a lymph node containing isolated tumor cells, micrometastasis, or macrometastasis. These pathology categories are reported separately. For the clinical analysis, pathology determines the nodal category using the standard dissection specimens alone and again after adding separately labeled second-look specimens. The patient-level rate of change in pathological nodal category is reported separately from the CSE rate. Any documented change in the postoperative treatment recommendation is recorded separately from a pathology finding. Procedure- and device-related adverse events are followed for 30 days.
The first 50 participants support a descriptive report of device feasibility and workflow, including scan completion, localization of additional foci, pathology of removed foci, time, and failures. The full 200-patient cohort supports estimation of CSE yield and nodal-category change with confidence intervals. There is no conventional near-infrared camera comparator. This single-arm study does not establish an improvement in recurrence, survival, or other patient outcomes.
- Being tested
- Augmented-reality ICG fluorescence second-look imaging
- Keywords
- indocyanine green, near-infrared fluorescence, fluorescence-guided surgery, augmented reality, axillary lymph node dissection, residual nodal disease, sentinel lymph node, breast cancer
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented-reality ICG fluorescence second-look imagingDevice
A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.
| Study group | Role | What they receive |
|---|---|---|
| AR-ICG Second-Look | Experimental | After the operating surgeon declares the axillary lymph node dissection complete, a brief augmented-reality ICG near-infrared fluorescence re-examination of the surgical field is performed. Additional fluorescent tissue is re-assessed under standard lighting and removed only if the surgeon judges removal safe and clinically appropriate; removed tissue undergoes separate histopathology. Receives: Device: Augmented-reality ICG fluorescence second-look imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level rate of clinically significant events (CSE)
Proportion of patients with at least one clinically significant event (CSE). A CSE is defined as additional fluorescent tissue identified at the second-look review after the surgeon's declared completion of the axillary dissection, not previously planned for removal, removed after re-assessment under standard lighting, and confirmed on final histopathology to be a lymph node containing tumor (isolated tumor cells, micrometastasis, or macrometastasis).
Measured: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)
Secondary outcomes (6)
Distribution of additional fluorescent findings by tissue category
Number of additional fluorescent findings classified on histopathology as tumor-positive lymph node, tumor-negative lymph node, or non-nodal tissue (e.g., fibro-adipose tissue or dye leakage).
Measured: Final histopathology (up to approximately 2 weeks after surgery)
Anatomic location of additional fluorescent findings
Anatomic location of each additional fluorescent finding, recorded as axillary level I, II, or III; interpectoral (Rotter); internal mammary; or other.
Measured: Intraoperative (day of surgery)
Nodal stage migration
Patient-level proportion whose pathological nodal category changes when separately labeled, pathology-confirmed second-look lymph nodes are added to the standard axillary dissection specimens. Determine pN first from the standard specimens alone and then from all specimens using the applicable breast cancer staging rules. Report the direction and category of each change; report isolated tumor cells separately and do not count them as positive nodes for pN thresholds.
Measured: Final histopathology (up to approximately 2 weeks after surgery)
Added operative time for the second-look review
Additional operative time required to perform the second-look review, in minutes.
Measured: Intraoperative (day of surgery)
Procedure- or device-related adverse events
Number of participants with adverse events related to the study procedure or device.
Measured: Through 30 days after surgery
AR/VR second-look technical completion rate
Proportion of participants in whom the planned AR/VR ICG second-look scan is completed with live fluorescence displayed over the exposed axillary field. Record incomplete scans, device failures, and the reason for each. Summarize this outcome for all enrolled participants and separately for the prespecified first 50 participants.
Measured: Intraoperative (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Single prospective cohort of 200 consecutive patients undergoing clinically indicated complete axillary lymph node dissection and an AR/VR ICG second look. The first 50 enrolled patients form a prespecified descriptive device-feasibility analysis; all 200 contribute to the full-cohort analysis of pathology-confirmed CSE and nodal-category change. The first 50 are a subset, not an additional arm. Earlier internal observations are not included.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ss. Cyril and Methodius University of Skopje
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Borislav Kondov, Ss. Cyril and Methodius University of Skopje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696754
- Sponsor's protocol ID
- UKIM-AR-ICG-BREAST-2026
- Acronym
- AR4SLN
- Status last verified
- Nov 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center study of up to 200 participants. Individual participant data are not planned to be shared. De-identified data may be made available from the principal investigator on reasonable request, subject to institutional approval.
Publications
de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialists' Group. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.
PubMed 38598571Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4.
PubMed 39966355Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.
PubMed 25439688Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
PubMed 28898379
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Augmented-Reality ICG Fluorescence Second-Look After Axillary Lymph Node Dissection in Breast Cancer
- ClinicalTrials.gov ID
- NCT07696754
- Acronym / sponsor ID
- AR4SLN / UKIM-AR-ICG-BREAST-2026
- Keywords
- indocyanine green, near-infrared fluorescence, fluorescence-guided surgery, augmented reality, axillary lymph node dissection, residual nodal disease, sentinel lymph node, breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ss. Cyril and Methodius University of SkopjeUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 10 Jul 2026 (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.
This prospective study will enroll up to 200 patients whose clinical team has already planned an axillary lymph node dissection for breast cancer. After the surgeon completes the planned dissection and declares that no further tissue was intended for removal, a wearable augmented-reality/virtual-reality (AR/VR) system will show indocyanine-green (ICG) near-infrared fluorescence during a brief second look at the exposed surgical field. The surgeon may remove an additional fluorescent focus only after inspection under normal light and only when removal is safe and clinically appropriate. Each additional specimen will be labeled separately and examined by pathology.
The study measures the proportion of patients with an additional tumor-positive lymph node found at second look, whether such nodes change the pathological nodal category, operating time, and adverse events. The first 50 consecutive participants will form a planned descriptive device-feasibility analysis; all 200 participants will contribute to the full-cohort clinical analysis. The study does not assume that finding an additional node improves recurrence or survival.
Detailed description
This is a prospective, single-center, single-arm study of 200 unique participants undergoing breast cancer surgery with axillary lymph node dissection independently indicated by the clinical team. Earlier observations from an internal, unregistered protocol are not included in this study population. The first 50 consecutive enrolled participants form a prespecified descriptive device-feasibility subset; they remain part of the full 200-patient cohort and are not a separate arm.
Before AR/VR imaging, the operating surgeon records the indication and extent of the planned axillary dissection and declares that the standard procedure and inspection are complete. A brief ICG near-infrared fluorescence second look is then performed with the wearable system within the already exposed operative field. Each additional fluorescent focus receives a unique identifier, anatomic location, image or video reference when available, and a record of whether it was visible or palpable under standard lighting. The surgeon reassesses the focus under standard lighting and removes it only when safe and clinically appropriate. Each removed focus is submitted separately for pathology. Negative scans, foci left in place, interrupted scans, device failures, and added operating time are recorded.
The primary outcome remains the patient-level rate of pathology-confirmed clinically significant events (CSE) already defined in this record: at least one additional fluorescent focus not planned for removal before the second look, removed after standard-light reassessment, and confirmed to be a lymph node containing isolated tumor cells, micrometastasis, or macrometastasis. These pathology categories are reported separately. For the clinical analysis, pathology determines the nodal category using the standard dissection specimens alone and again after adding separately labeled second-look specimens. The patient-level rate of change in pathological nodal category is reported separately from the CSE rate. Any documented change in the postoperative treatment recommendation is recorded separately from a pathology finding. Procedure- and device-related adverse events are followed for 30 days.
The first 50 participants support a descriptive report of device feasibility and workflow, including scan completion, localization of additional foci, pathology of removed foci, time, and failures. The full 200-patient cohort supports estimation of CSE yield and nodal-category change with confidence intervals. There is no conventional near-infrared camera comparator. This single-arm study does not establish an improvement in recurrence, survival, or other patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single prospective cohort of 200 consecutive patients undergoing clinically indicated complete axillary lymph node dissection and an AR/VR ICG second look. The first 50 enrolled patients form a prespecified descriptive device-feasibility analysis; all 200 contribute to the full-cohort analysis of pathology-confirmed CSE and nodal-category change. The first 50 are a subset, not an additional arm. Earlier internal observations are not included.
| Arm | Type | Receives |
|---|---|---|
| AR-ICG Second-Look | Experimental | Device: Augmented-reality ICG fluorescence second-look imagingAfter the operating surgeon declares the axillary lymph node dissection complete, a brief augmented-reality ICG near-infrared fluorescence re-examination of the surgical field is performed. Additional fluorescent tissue is re-assessed under standard lighting and removed only if the surgeon judges removal safe and clinically appropriate; removed tissue undergoes separate histopathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven breast cancer
- Age 18 years or older
- Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection
- Provides written informed consent
Key exclusion criteria (6 listed)
- Pregnancy
- Neoadjuvant chemotherapy
- Prior breast surgery
- Iodine or seafood allergy
- Indocyanine green (ICG) allergy
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 |
|---|---|---|
| Augmented-reality ICG fluorescence second-look imagingA wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol. | Device | AR-ICG Second-Look |
Primary outcome
Patient-level rate of clinically significant events (CSE)
Time frame: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)
Proportion of patients with at least one clinically significant event (CSE). A CSE is defined as additional fluorescent tissue identified at the second-look review after the surgeon's declared completion of the axillary dissection, not previously planned for removal, removed after re-assessment under standard lighting, and confirmed on final histopathology to be a lymph node containing tumor (isolated tumor cells, micrometastasis, or macrometastasis).
6 secondary outcomes
Distribution of additional fluorescent findings by tissue category
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Anatomic location of additional fluorescent findings
Time frame: Intraoperative (day of surgery)
Nodal stage migration
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Added operative time for the second-look review
Time frame: Intraoperative (day of surgery)
Procedure- or device-related adverse events
Time frame: Through 30 days after surgery
AR/VR second-look technical completion rate
Time frame: Intraoperative (day of surgery)
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 6 Nov 2026.
- Results publication: PubMed 38598571de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialists' Group. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.
- Results publication: PubMed 39966355Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4.
- Results publication: PubMed 25439688Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.
- Results publication: PubMed 28898379Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
- Individual participant dataSharing planned: No. This is a single-center study of up to 200 participants. Individual participant data are not planned to be shared. De-identified data may be made available from the principal investigator on reasonable request, subject to institutional approval.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented-reality ICG fluorescence second-look imaging in people with Breast Cancer and Breast Neoplasms, run by Ss. Cyril and Methodius University of Skopje at 1 site in North Macedonia.
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 4 inclusion and 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Borislav Kondov, MD (+38972539003, borislav.kondov@medf.ukim.edu.mk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-level rate of clinically significant events (CSE) (time frame: From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07696754, which also lists 4 linked publications.
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 6 Nov 2026.