Lung CancerNCT04684186
Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer
An observational study of Lung Cancer and Lung Metastases, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer (1). Recent advances in Cyberknife© technology, which is a robotic system of stereotactic irradiation including localisation and real time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Metastases, Radiotherapy
- What is being tested?
- Endovascular fiducial marker insertion and Bronchoscopic fiducial marker insertion
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2016to 1 Jun 2026
- Phase
- Observational
- 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
Study population: Patients with lung cancer (1ary and 2ndary), not eligible for surgery, and treated by radiation therapy needing a fiducial marker placement will be eligible for this study which is a prospective randomized controlled trial (endovascular vs endobronchic fiducial marker).
Who may be able to join
- Lung cancer (primary or secondary, any histological type)
- Early stage lung cancer: patients diagnosed with stage I for which operation is contra-indicated, for example because of cardiac or pulmonary comorbidities.
- Locally advanced lung cancer stages II - IIIB
- Metastatic lung cancer stage IV (palliative care)
- 18 y ≤ age ≤ 85 y
Who cannot join
- age <18y
- incapacity of judgment
- Absence of a signed consent form
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology
Lausanne, Canton of Vaud, 1011
Rafael DURAN, +41213144444, rafael.duran@chuv.ch
About this study
Official title: Real-time Guided Stereotactic Radiotherapy in Lung Cancer Using Endovascular Coils for Tumor Marking: Head-to-head Comparison Between Endovascular and Bronchoscopic Fiducial Marker Insertion
The role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer (1).
Recent advances in Cyberknife© technology, which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking, has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). According to several studies, promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with Cyberknife© (4)(5)(6)(7)(8).
Read more
Fiducial markers are implanted in or near a tumor in a configuration defining a COM (center of mass) guiding the Cyberknife for tumor localization.
Tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation. Change in marker positioning leads to COM alterations, thus limiting detection by the tracking system.
Percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in previous studies as feasible and safe procedures, providing accurate tracking.
Few studies are currently available in the litterature comparing these modalities (19)(20). The percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax (9).
Both the endobronchial and endovascular technique have been described in the literature with equivalent success rate (87-90%) in intention to treat (21)(22).
One of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement, complications rates and procedure time.
- Conditions
- Lung Cancer, Lung Metastases, Radiotherapy
- Being tested
- Endovascular fiducial marker insertion, Bronchoscopic fiducial marker insertion
- Keywords
- fiducial marker placement, stereotactic body radiotherapy, interventional radiology
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular fiducial marker insertionProcedure or surgery
Fiducial markers will be inserted using an endovascular route
Bronchoscopic fiducial marker insertionProcedure or surgery
Fiducial markers will be inserted using an endoscopic route
| Study group | Role | What they receive |
|---|---|---|
| Endovascular fiducial marker insertion | Fiducial markers are inserted and released near the tumor through femoral puncture. A catheter is led through the venous system to the right heart and from there through the heart into the pulmonary arteries. Receives: Procedure: Endovascular fiducial marker insertion | |
| Bronchoscopic fiducial marker insertion | Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route Receives: Procedure: Bronchoscopic fiducial marker insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyberknife© tracking
Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation
Measured: Before Cyberknife
Secondary outcomes (4)
Fiducial implantation evaluation by operator
Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques
Measured: Immediately post-implantation
Fiducial marker migration
Secondary fiducial migration rate assessment in both techniques
Measured: Immediately post-implantation and before Cyberknife
Procedure time
Procedure time required for the implantation of three markers around the lung tumor in both techniques
Measured: Immediately after the procedure
Complication rate
Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques
Measured: within 30 days of fiducial marker placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start10 Oct 2016
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael DURAN, MD, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684186
- Sponsor's protocol ID
- 2016-00046
- Other IDs
- 2016
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hagmeyer L, Priegnitz C, Kocher M, Schilcher B, Budach W, Treml M, Stieglitz S, Randerath W. Fiducial marker placement via conventional or electromagnetic navigation bronchoscopy (ENB): an interdisciplinary approach to the curative management of lung cancer. Clin Respir J. 2016 May;10(3):291-7. doi: 10.1111/crj.12214. Epub 2014 Nov 3.
PubMed 25308297Harada T, Shirato H, Ogura S, Oizumi S, Yamazaki K, Shimizu S, Onimaru R, Miyasaka K, Nishimura M, Dosaka-Akita H. Real-time tumor-tracking radiation therapy for lung carcinoma by the aid of insertion of a gold marker using bronchofiberscopy. Cancer. 2002 Oct 15;95(8):1720-7. doi: 10.1002/cncr.10856.
PubMed 12365020Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17.
PubMed 21685461Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
PubMed 23485231Detterbeck FC, Lewis SZ, Diekemper R, Addrizzo-Harris D, Alberts WM. Executive Summary: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):7S-37S. doi: 10.1378/chest.12-2377. No abstract available.
PubMed 23649434Detterbeck FC. Lobectomy versus limited resection in T1N0 lung cancer. Ann Thorac Surg. 2013 Aug;96(2):742-4. doi: 10.1016/j.athoracsur.2013.03.074. No abstract available.
PubMed 23910135Stefani A, Nesci J, Casali C, Morandi U. Wedge resection versus lobectomy for T1N0 non-small cell lung cancer. Minerva Chir. 2012 Dec;67(6):489-98.
PubMed 23334112Ahn SH, Han MS, Yoon JH, Jeon SY, Kim CH, Yoo HJ, Lee JC. Treatment of stage I non-small cell lung cancer with CyberKnife, image-guided robotic stereotactic radiosurgery. Oncol Rep. 2009 Mar;21(3):693-6.
PubMed 19212628Shen ZT, Wu XH, Li B, Zhu XX. Clinical outcomes of CyberKnife stereotactic body radiotherapy for peripheral stage I non-small cell lung cancer. Med Oncol. 2015 Mar;32(3):55. doi: 10.1007/s12032-015-0506-1. Epub 2015 Feb 1.
PubMed 25638468van der Voort van Zyp NC, Hoogeman MS, van de Water S, Levendag PC, van der Holt B, Heijmen BJ, Nuyttens JJ. Stability of markers used for real-time tumor tracking after percutaneous intrapulmonary placement. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e75-81. doi: 10.1016/j.ijrobp.2010.12.026. Epub 2011 Feb 23.
PubMed 21349655Patel A, Khalsa B, Lord B, Sandrasegaran K, Lall C. Planting the seeds of success: CT-guided gold seed fiducial marker placement to guide robotic radiosurgery. J Med Imaging Radiat Oncol. 2013 Apr;57(2):207-11. doi: 10.1111/j.1754-9485.2012.02445.x. Epub 2012 Sep 21.
PubMed 23551782Habermehl D, Henkner K, Ecker S, Jakel O, Debus J, Combs SE. Evaluation of different fiducial markers for image-guided radiotherapy and particle therapy. J Radiat Res. 2013 Jul;54 Suppl 1(Suppl 1):i61-8. doi: 10.1093/jrr/rrt071.
PubMed 23824129Chan MF, Cohen GN, Deasy JO. Qualitative evaluation of fiducial markers for radiotherapy imaging. Technol Cancer Res Treat. 2015 Jun;14(3):298-304. doi: 10.1177/1533034614547447. Epub 2014 Sep 16.
PubMed 25230715Pepin E, Olsen L, Badiyan S, Murad F, Mullady D, Wang-Gillam A, Linehan D, Parikh P, Olsen J. Comparison of implanted fiducial markers and self-expandable metallic stents for pancreatic image guided radiation therapy localization. Pract Radiat Oncol. 2015 May-Jun;5(3):e193-e199. doi: 10.1016/j.prro.2014.08.019. Epub 2014 Oct 3.
PubMed 25413391Boschini FJ, Commander CW, Schreiber EC, Yu H, Dixon RG. Comparison of Gold Seeds, Tight Embolization Coils, and Loose Embolization Coils Used as Fiducial Markers for Dynamic Tracking Using CyberKnife. Pract Radiat Oncol. 2013 Apr-Jun;3(2 Suppl 1):S22. doi: 10.1016/j.prro.2013.01.074. Epub 2013 Mar 25. No abstract available.
PubMed 24674518
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Guided Stereotactic Radiotherapy in Lung Cancer Using Endovascular Coils for Tumor Marking: Head-to-head Comparison Between Endovascular and Bronchoscopic Fiducial Marker Insertion
- ClinicalTrials.gov ID
- NCT04684186
- Acronym / sponsor ID
- 2016-00046
- Conditions
- Lung Cancer, Lung Metastases, Radiotherapy
- Keywords
- fiducial marker placement, stereotactic body radiotherapy, interventional radiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Dec 2020 (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 role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer (1).
Recent advances in Cyberknife© technology, which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking, has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). According to several studies, promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with Cyberknife© (4)(5)(6)(7)(8).
Fiducial markers are implanted in or near a tumor in a configuration defining a COM (center of mass) guiding the Cyberknife for tumor localization.
Tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation. Change in marker positioning leads to COM alterations, thus limiting detection by the tracking system.
Percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in previous studies as feasible and safe procedures, providing accurate tracking.
Few studies are currently available in the litterature comparing these modalities (19)(20). The percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax (9).
Both the endobronchial and endovascular technique have been described in the literature with equivalent success rate (87-90%) in intention to treat (21)(22).
One of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement, complications rates and procedure time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular fiducial marker insertion | – | Procedure: Endovascular fiducial marker insertionFiducial markers are inserted and released near the tumor through femoral puncture. A catheter is led through the venous system to the right heart and from there through the heart into the pulmonary arteries. |
| Bronchoscopic fiducial marker insertion | – | Procedure: Bronchoscopic fiducial marker insertionFiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer (1ary and 2ndary), not eligible for surgery, and treated by radiation therapy needing a fiducial marker placement will be eligible for this study which is a prospective randomized controlled trial (endovascular vs endobronchic fiducial marker).
Key inclusion criteria (5 listed)
- Lung cancer (primary or secondary, any histological type)
- Early stage lung cancer: patients diagnosed with stage I for which operation is contra-indicated, for example because of cardiac or pulmonary comorbidities.
- Locally advanced lung cancer stages II - IIIB
- Metastatic lung cancer stage IV (palliative care)
- 18 y ≤ age ≤ 85 y
Key exclusion criteria (3 listed)
- age <18y
- incapacity of judgment
- Absence of a signed consent form
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 |
|---|---|---|
| Endovascular fiducial marker insertionFiducial markers will be inserted using an endovascular route | Procedure or surgery | Endovascular fiducial marker insertion |
| Bronchoscopic fiducial marker insertionFiducial markers will be inserted using an endoscopic route | Procedure or surgery | Bronchoscopic fiducial marker insertion |
Primary outcome
Cyberknife© tracking
Time frame: Before Cyberknife
Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation
4 secondary outcomes
Fiducial implantation evaluation by operator
Time frame: Immediately post-implantation
Fiducial marker migration
Time frame: Immediately post-implantation and before Cyberknife
Procedure time
Time frame: Immediately after the procedure
Complication rate
Time frame: within 30 days of fiducial marker placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 25308297Hagmeyer L, Priegnitz C, Kocher M, Schilcher B, Budach W, Treml M, Stieglitz S, Randerath W. Fiducial marker placement via conventional or electromagnetic navigation bronchoscopy (ENB): an interdisciplinary approach to the curative management of lung cancer. Clin Respir J. 2016 May;10(3):291-7. doi: 10.1111/crj.12214. Epub 2014 Nov 3.
- Background: PubMed 12365020Harada T, Shirato H, Ogura S, Oizumi S, Yamazaki K, Shimizu S, Onimaru R, Miyasaka K, Nishimura M, Dosaka-Akita H. Real-time tumor-tracking radiation therapy for lung carcinoma by the aid of insertion of a gold marker using bronchofiberscopy. Cancer. 2002 Oct 15;95(8):1720-7. doi: 10.1002/cncr.10856.
- Background: PubMed 21685461Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17.
- Background: PubMed 23485231Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
- Background: PubMed 23649434Detterbeck FC, Lewis SZ, Diekemper R, Addrizzo-Harris D, Alberts WM. Executive Summary: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):7S-37S. doi: 10.1378/chest.12-2377. No abstract available.
- Background: PubMed 23910135Detterbeck FC. Lobectomy versus limited resection in T1N0 lung cancer. Ann Thorac Surg. 2013 Aug;96(2):742-4. doi: 10.1016/j.athoracsur.2013.03.074. No abstract available.
- Background: PubMed 23334112Stefani A, Nesci J, Casali C, Morandi U. Wedge resection versus lobectomy for T1N0 non-small cell lung cancer. Minerva Chir. 2012 Dec;67(6):489-98.
- Background: PubMed 19212628Ahn SH, Han MS, Yoon JH, Jeon SY, Kim CH, Yoo HJ, Lee JC. Treatment of stage I non-small cell lung cancer with CyberKnife, image-guided robotic stereotactic radiosurgery. Oncol Rep. 2009 Mar;21(3):693-6.
- Background: PubMed 25638468Shen ZT, Wu XH, Li B, Zhu XX. Clinical outcomes of CyberKnife stereotactic body radiotherapy for peripheral stage I non-small cell lung cancer. Med Oncol. 2015 Mar;32(3):55. doi: 10.1007/s12032-015-0506-1. Epub 2015 Feb 1.
- Background: PubMed 21349655van der Voort van Zyp NC, Hoogeman MS, van de Water S, Levendag PC, van der Holt B, Heijmen BJ, Nuyttens JJ. Stability of markers used for real-time tumor tracking after percutaneous intrapulmonary placement. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e75-81. doi: 10.1016/j.ijrobp.2010.12.026. Epub 2011 Feb 23.
- Background: PubMed 23551782Patel A, Khalsa B, Lord B, Sandrasegaran K, Lall C. Planting the seeds of success: CT-guided gold seed fiducial marker placement to guide robotic radiosurgery. J Med Imaging Radiat Oncol. 2013 Apr;57(2):207-11. doi: 10.1111/j.1754-9485.2012.02445.x. Epub 2012 Sep 21.
- Background: PubMed 23824129Habermehl D, Henkner K, Ecker S, Jakel O, Debus J, Combs SE. Evaluation of different fiducial markers for image-guided radiotherapy and particle therapy. J Radiat Res. 2013 Jul;54 Suppl 1(Suppl 1):i61-8. doi: 10.1093/jrr/rrt071.
Related trials for Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung Metastases, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael DURAN, MD (+41213144444, rafael.duran@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyberknife© tracking (time frame: Before Cyberknife). 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 NCT04684186, which also lists 22 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 12 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.