Breast Cancer FemaleNCT04826211
Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI
A study testing PET/MRI in people with Breast Cancer Female and Node-positive Breast Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Female, Node-positive Breast Cancer, Sentinel Lymph Node
- What is being tested?
- PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Age > 18 years;
- Proven diagnosis of early BC of any size;
- Patients candidate to primary systemic therapy (PST);
- Positive axillary nodes at diagnosis, confirmed by either citology or histology confirmation. Patients with clear overt clinical and radiological nodal involvement might be enrolled as well without FNA or microhystology
Who cannot join
- inflammatory BC;
- pregnancy;
- contraindication to PET;
- distant metastases;
- no surgery after PST;
- contraindication to MRI;
Show all 9Show fewer
- claustrophobia;
- allergy to the MR contrast agent;
- severe renal insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting the Future of Axillary Staging in Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.
The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy.
It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance.
Read the detailed description
HYPOTHESIS: Hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging modality to accurately define nodal status after PST, properly select type of surgical approach and might eventually lead to the omission of axillar surgery in some breast cancer patients showing complete imaging response.
AIMS: The primary endpoint is to compare the staging power between SNB (or lymphoadenectomy) vs PET/MRI in detecting axillary lymph node macro-metastases (>2 mm).Additionally the PET/MRI and A-US results will be confronted and ultimately related to pathology result, calculating the concordance rate in terms of positive vs negative nodes and number of positive nodes detected by each method. The staging power of both preoperative exams will be evaluated by considering how many times the results from PET/MRI or A-US could have indicated the most appropriate axillary treatment according to pathological findings.
EXPERIMENTAL DESIGN: Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI prior to PST.
The study population will then be split into two groups:
- women with positive axillary lymph nodes after PST (Group 1, 60% of the total)
- women with negative axillary lymph nodes after PST (Group 2, 40% of the total).
A total of 110 women will guarantee two well-powered independent analysis. one for Group 1 (n=66; power>90%; Type I error rate of 0.05) and one for Group 2 (n=44; power>80%; Type I error rate of 0.05).
- Being tested
- PET/MRI
- Keywords
- primary systemic therapy, node positive breast cancer, surgery after primary systemic therapy, PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
All included patients will undergo PET/MRI both prior to PST and prior to surgery. In order to analyze results the population will be divided into two groups: women with positive axillary lymph nodes after PST (Group 1) and women with negative axillary lymph nodes after PST (Group 2).
| Study group | Role | What they receive |
|---|---|---|
| Node positive BC patients undergoing PST | Experimental | Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI both prior to PST and after PST before surgery Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary surgery vs PET/MRI.
Results from SNB (Sentinel Node Biopsy), AD (Axillary Dissection) or any axillary surgery will be compared to results from preoperative PET/MRI.
Measured: Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI
Secondary outcomes (2)
Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound)
Results on the status of axillary nodes from preoperative A-US will be compared to results of preoperative PET/MRI.
Measured: At 12 months
Correlation between PET/MRI parameters and prognosis
Quantitative analysis of PET/MRI exams will allow to extract standard imaging biomarkers to be correlated with tumour clinical and pathological data. Image analysis will be carried out both at staging and at the end of PST.
Functional parameters from PET image analysis include Standardized Uptake Value and Metabolic Tumor Volume.
From breast MR images, the quantitative and semiquantitative data are related to DWI and DCE MR sequences. Specifically, from the so-called Time Intensity Curve (TIC) obtained from the dynamic DCE some parameters can be extracted, for example Time To Peak, Peak Enhancement Percentage, Signal Enhancement Ratio and Initial Enhancement Percentage. From DWI MR sequence Apparent Diffusion Coefficient map can be calculated.
Measured: At baseline and at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start4 Nov 2019
- Primary completion30 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Responsible party
- Principal investigator, Oreste Davide Gentilini, IRCCS San Raffaele
- Investigators
- GENTILINI, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826211
- Sponsor's protocol ID
- SNB vs PET/MRI 1
- Status last verified
- Jul 2025
- First submitted
- 25 May 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taneja S, Jena A, Goel R, Sarin R, Kaul S. Simultaneous whole-body (1)(8)F-FDG PET-MRI in primary staging of breast cancer: a pilot study. Eur J Radiol. 2014 Dec;83(12):2231-2239. doi: 10.1016/j.ejrad.2014.09.008. Epub 2014 Sep 28.
PubMed 25282709Melsaether AN, Raad RA, Pujara AC, Ponzo FD, Pysarenko KM, Jhaveri K, Babb JS, Sigmund EE, Kim SG, Moy LA. Comparison of Whole-Body (18)F FDG PET/MR Imaging and Whole-Body (18)F FDG PET/CT in Terms of Lesion Detection and Radiation Dose in Patients with Breast Cancer. Radiology. 2016 Oct;281(1):193-202. doi: 10.1148/radiol.2016151155. Epub 2016 Mar 29.
PubMed 27023002Veronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G, Spano G, Luini A, Intra M, Veronesi P, Berrettini A, Paganelli G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Ann Oncol. 2007 Mar;18(3):473-8. doi: 10.1093/annonc/mdl425. Epub 2006 Dec 12.
PubMed 17164229Gentilini O, Veronesi U. Staging the Axilla in Early Breast Cancer: Will Imaging Replace Surgery? JAMA Oncol. 2015 Nov;1(8):1031-2. doi: 10.1001/jamaoncol.2015.2337. No abstract available.
PubMed 26291922van Nijnatten TJA, Goorts B, Voo S, de Boer M, Kooreman LFS, Heuts EM, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Added value of dedicated axillary hybrid 18F-FDG PET/MRI for improved axillary nodal staging in clinically node-positive breast cancer patients: a feasibility study. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):179-186. doi: 10.1007/s00259-017-3823-0. Epub 2017 Sep 14.
PubMed 28905091Heusch P, Nensa F, Schaarschmidt B, Sivanesapillai R, Beiderwellen K, Gomez B, Kohler J, Reis H, Ruhlmann V, Buchbender C. Diagnostic accuracy of whole-body PET/MRI and whole-body PET/CT for TNM staging in oncology. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):42-8. doi: 10.1007/s00259-014-2885-5. Epub 2014 Aug 12.
PubMed 25112399Stadnik TW, Everaert H, Makkat S, Sacre R, Lamote J, Bourgain C. Breast imaging. Preoperative breast cancer staging: comparison of USPIO-enhanced MR imaging and 18F-fluorodeoxyglucose (FDC) positron emission tomography (PET) imaging for axillary lymph node staging--initial findings. Eur Radiol. 2006 Oct;16(10):2153-60. doi: 10.1007/s00330-006-0276-4. Epub 2006 May 3.
PubMed 16670863Di Micco R, Botteri E, Canevari C, Gallivanone F, Antunovic L, Scifo P, Neri I, Gelardi F, Magnani P, Losio C, Venturini E, Della Vecchia G, Ferrarese G, Rotmensz N, Zuber V, Baleri S, Cisternino G, Calabretto F, Corona SP, Rampa M, Hammami DWS, Scaduto V, Morgante MM, Viale G, Piras M, Licata L, Sassi I, Bianchini G, Panizza P, Chiti A, Gentilini OD. [18F]FDG PET/MRI for axillary staging in node positive breast cancer patients receiving primary systemic therapy. A prospective single arm trial. Breast. 2026 Jul 20;89:104875. doi: 10.1016/j.breast.2026.104875. Online ahead of print.
PubMed 42492092Di Micco R, Saracoglu S, Pfob A, Canevari C, Gallivanone F, Antunovic L, Gelardi F, Scifo P, Neri I, Losio C, Venturini E, Della Vecchia G, Ferrarese G, Rotmensz N, Zuber V, Baleri S, Cisternino G, Corona SP, Calabretto F, Rampa M, Licata L, Viale G, Zambelli S, Sassi I, Bianchini G, Panizza P, Chiti A, Heil J, Gentilini OD. Diagnostic accuracy of modern imaging following neoadjuvant therapy for breast cancer: a comparative analysis of ultrasound versus [18F] FDG PET/MRI in breast response assessment. Front Oncol. 2026 Jun 18;16:1845216. doi: 10.3389/fonc.2026.1845216. eCollection 2026.
PubMed 42394696
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Future of Axillary Staging in Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.
- ClinicalTrials.gov ID
- NCT04826211
- Acronym / sponsor ID
- SNB vs PET/MRI 1
- Keywords
- primary systemic therapy, node positive breast cancer, surgery after primary systemic therapy, PET/MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Apr 2021 (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.
The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy.
It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance.
Detailed description
HYPOTHESIS: Hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging modality to accurately define nodal status after PST, properly select type of surgical approach and might eventually lead to the omission of axillar surgery in some breast cancer patients showing complete imaging response.
AIMS: The primary endpoint is to compare the staging power between SNB (or lymphoadenectomy) vs PET/MRI in detecting axillary lymph node macro-metastases (>2 mm).Additionally the PET/MRI and A-US results will be confronted and ultimately related to pathology result, calculating the concordance rate in terms of positive vs negative nodes and number of positive nodes detected by each method. The staging power of both preoperative exams will be evaluated by considering how many times the results from PET/MRI or A-US could have indicated the most appropriate axillary treatment according to pathological findings.
EXPERIMENTAL DESIGN: Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI prior to PST.
The study population will then be split into two groups:
- women with positive axillary lymph nodes after PST (Group 1, 60% of the total)
- women with negative axillary lymph nodes after PST (Group 2, 40% of the total).
A total of 110 women will guarantee two well-powered independent analysis. one for Group 1 (n=66; power>90%; Type I error rate of 0.05) and one for Group 2 (n=44; power>80%; Type I error rate of 0.05).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Node positive BC patients undergoing PST | Experimental | Diagnostic Test: PET/MRIPatients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI both prior to PST and after PST before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent;
- Age > 18 years;
- Proven diagnosis of early BC of any size;
- Patients candidate to primary systemic therapy (PST);
- Positive axillary nodes at diagnosis, confirmed by either citology or histology confirmation. Patients with clear overt clinical and radiological nodal involvement might be enrolled as well without FNA or microhystology
Key exclusion criteria (9 listed)
- inflammatory BC;
- pregnancy;
- contraindication to PET;
- distant metastases;
- no surgery after PST;
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 |
|---|---|---|
| PET/MRIAll included patients will undergo PET/MRI both prior to PST and prior to surgery. In order to analyze results the population will be divided into two groups: women with positive axillary lymph nodes after PST (Group 1) and women with negative axillary lymph nodes after PST (Group 2). | Diagnostic test | Node positive BC patients undergoing PST |
Primary outcome
Axillary surgery vs PET/MRI.
Time frame: Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI
Results from SNB (Sentinel Node Biopsy), AD (Axillary Dissection) or any axillary surgery will be compared to results from preoperative PET/MRI.
2 secondary outcomes
Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound)
Time frame: At 12 months
Correlation between PET/MRI parameters and prognosis
Time frame: At baseline and at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 25282709Taneja S, Jena A, Goel R, Sarin R, Kaul S. Simultaneous whole-body (1)(8)F-FDG PET-MRI in primary staging of breast cancer: a pilot study. Eur J Radiol. 2014 Dec;83(12):2231-2239. doi: 10.1016/j.ejrad.2014.09.008. Epub 2014 Sep 28.
- Background: PubMed 27023002Melsaether AN, Raad RA, Pujara AC, Ponzo FD, Pysarenko KM, Jhaveri K, Babb JS, Sigmund EE, Kim SG, Moy LA. Comparison of Whole-Body (18)F FDG PET/MR Imaging and Whole-Body (18)F FDG PET/CT in Terms of Lesion Detection and Radiation Dose in Patients with Breast Cancer. Radiology. 2016 Oct;281(1):193-202. doi: 10.1148/radiol.2016151155. Epub 2016 Mar 29.
- Background: PubMed 17164229Veronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G, Spano G, Luini A, Intra M, Veronesi P, Berrettini A, Paganelli G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Ann Oncol. 2007 Mar;18(3):473-8. doi: 10.1093/annonc/mdl425. Epub 2006 Dec 12.
- Background: PubMed 26291922Gentilini O, Veronesi U. Staging the Axilla in Early Breast Cancer: Will Imaging Replace Surgery? JAMA Oncol. 2015 Nov;1(8):1031-2. doi: 10.1001/jamaoncol.2015.2337. No abstract available.
- Background: PubMed 28905091van Nijnatten TJA, Goorts B, Voo S, de Boer M, Kooreman LFS, Heuts EM, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Added value of dedicated axillary hybrid 18F-FDG PET/MRI for improved axillary nodal staging in clinically node-positive breast cancer patients: a feasibility study. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):179-186. doi: 10.1007/s00259-017-3823-0. Epub 2017 Sep 14.
- Background: PubMed 25112399Heusch P, Nensa F, Schaarschmidt B, Sivanesapillai R, Beiderwellen K, Gomez B, Kohler J, Reis H, Ruhlmann V, Buchbender C. Diagnostic accuracy of whole-body PET/MRI and whole-body PET/CT for TNM staging in oncology. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):42-8. doi: 10.1007/s00259-014-2885-5. Epub 2014 Aug 12.
- Background: PubMed 16670863Stadnik TW, Everaert H, Makkat S, Sacre R, Lamote J, Bourgain C. Breast imaging. Preoperative breast cancer staging: comparison of USPIO-enhanced MR imaging and 18F-fluorodeoxyglucose (FDC) positron emission tomography (PET) imaging for axillary lymph node staging--initial findings. Eur Radiol. 2006 Oct;16(10):2153-60. doi: 10.1007/s00330-006-0276-4. Epub 2006 May 3.
- Derived from this study: PubMed 42492092Di Micco R, Botteri E, Canevari C, Gallivanone F, Antunovic L, Scifo P, Neri I, Gelardi F, Magnani P, Losio C, Venturini E, Della Vecchia G, Ferrarese G, Rotmensz N, Zuber V, Baleri S, Cisternino G, Calabretto F, Corona SP, Rampa M, Hammami DWS, Scaduto V, Morgante MM, Viale G, Piras M, Licata L, Sassi I, Bianchini G, Panizza P, Chiti A, Gentilini OD. [18F]FDG PET/MRI for axillary staging in node positive breast cancer patients receiving primary systemic therapy. A prospective single arm trial. Breast. 2026 Jul 20;89:104875. doi: 10.1016/j.breast.2026.104875. Online ahead of print.
- Derived from this study: PubMed 42394696Di Micco R, Saracoglu S, Pfob A, Canevari C, Gallivanone F, Antunovic L, Gelardi F, Scifo P, Neri I, Losio C, Venturini E, Della Vecchia G, Ferrarese G, Rotmensz N, Zuber V, Baleri S, Cisternino G, Corona SP, Calabretto F, Rampa M, Licata L, Viale G, Zambelli S, Sassi I, Bianchini G, Panizza P, Chiti A, Heil J, Gentilini OD. Diagnostic accuracy of modern imaging following neoadjuvant therapy for breast cancer: a comparative analysis of ultrasound versus [18F] FDG PET/MRI in breast response assessment. Front Oncol. 2026 Jun 18;16:1845216. doi: 10.3389/fonc.2026.1845216. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
GENTILINI principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Breast Cancer Female and Node-positive Breast Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 1 Aug 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary surgery vs PET/MRI. (time frame: Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI). 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 NCT04826211, which also lists 9 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 1 Aug 2025.