Atherosclerotic DiseaseSCORPIONNCT06886958
Spectral CT Protocol Optimization for Atherosclerotic Plaque CharacterizatION
An observational study of Atherosclerotic Disease, run by IRCCS SYNLAB SDN at 1 site in Italy.
Trial summary
The SCORPION study (Spectral CT Protocol Optimization for Atherosclerotic Plaque Characterization) is a retrospective and prospective observational research project aimed at improving the diagnostic accuracy of dual-energy CT (DECT) and photon-counting CT (PCCT) in the characterization of atherosclerotic plaques in… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atherosclerotic Disease
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2023to 30 Apr 2025
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects over 60 years of age performing a cardiovascular imaging examination
Who may be able to join
- Patients who have undergone DECT for cardiovascular imaging (coronary and/or carotid)
- Patients with critical stenosis (>75% diameter, coronary or carotid artery) aged > 60aa
Who cannot join
- Patients negative for critical stenosis (<75% diameter) and/or imaging artefacts (e.g. due to movement, swallowing, or arrhythmias).
- Patients under 60 years of age
- Patients allergic to iodinated contrast medium (prospective phase)
- Patients with chronic renal insufficiency (prospective phase)
Trial locations and contacts
1 site in 1 country.
About this study
The SCORPION study (Spectral CT Protocol Optimization for Atherosclerotic Plaque Characterization) is a retrospective and prospective observational research project aimed at improving the diagnostic accuracy of dual-energy CT (DECT) and photon-counting CT (PCCT) in the characterization of atherosclerotic plaques in the coronary and carotid arteries. Given that cardiovascular diseases remain a leading cause of mortality despite advances in prevention and treatment, optimizing non-invasive imaging methods is crucial. CT Angiography (CTA) has become the gold standard for diagnosing coronary artery disease and carotid stenosis, but existing techniques require enhancement to improve plaque characterization, which is vital for risk stratification and patient management. While DECT has demonstrated potential in differentiating tissue types, its clinical adoption has been slow due to a lack of broad validation. This study seeks to establish a standardized imaging protocol that will provide more precise and reproducible plaque characterization.
The primary objective of the study is to develop a standardized method for characterizing atherosclerotic plaques using DECT based on retrospective datasets from Synlab. The first secondary objective is to validate this workflow with photon-counting CT data from an independent cohort at Fondazione Monasterio/CNR, ensuring the reliability of the technique across different imaging modalities. The second secondary objective involves defining an optimized DECT protocol using the energy spectrum of PCCT, ultimately refining imaging parameters for improved plaque assessment.
Read more
The study is structured into two phases. In the retrospective phase, data from fifty patients with critical stenosis (greater than 75% narrowing of the artery) who previously underwent DECT scans are analyzed. This step focuses on optimizing imaging parameters, segmentation techniques, and post-processing workflows. In the prospective phase, another cohort of fifty patients undergoes scanning with photon-counting CT to validate the workflow developed in the first phase. The results will inform the refinement of an optimized DECT protocol, translating the benefits of photon-counting technology into more widely available DECT scanners.
Patients included in the study must be at least sixty years old and have undergone DECT for cardiovascular imaging of the coronary or carotid arteries. The imaging process involves a third-generation dual-energy CT scanner (Somatom Force, Siemens) with high-resolution imaging settings, dual-energy tube voltages of 150 and 90 kV, ECG-gated acquisition, and the use of iodine contrast. The collected data is processed using various reconstruction techniques to extract quantitative imaging biomarkers, including total plaque volume, non-calcified and calcified plaque volumes, remodeling index, and degree of luminal stenosis. The study employs PyRadiomics, an open-source platform for radiomic feature extraction, to standardize data analysis and improve reproducibility.
The expected outcome of this research is an improved molecular characterization of atherosclerosis, leading to more accurate risk stratification and predictive models for cardiovascular events. By refining imaging techniques, the study aims to enhance diagnostic precision and minimize unnecessary hospitalizations, ultimately improving patient outcomes. Furthermore, establishing a standardized DECT protocol will allow for broader clinical adoption, making advanced plaque characterization more accessible in routine cardiovascular assessments.
- Conditions
- Atherosclerotic Disease
- Keywords
- Atherosclerotic Plaque, Dual-Energy CT (DECT), Photon-Counting CT (PCCT), Radiomics, Cardiovascular Risk Stratification
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Imaging patiets | Patients who have undergone DECT for cardiovascular imaging (coronary and/or carotid) or with critical stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging analyses
Extraction of numerical data from imaging for the generation of a reproducible and standardized method for characterising the various components of atherosclerotic plaques
Measured: 1 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start31 Mar 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS SYNLAB SDN
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Monasterio/CNR
- Responsible party
- Sponsor
- Investigators
- Carlo Cavaliere, MD, Principal investigator, carlo.cavaliere@synlab.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886958
- Sponsor's protocol ID
- 7/22
- Acronym
- SCORPION
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Griethuysen JJM, Fedorov A, Parmar C, Hosny A, Aucoin N, Narayan V, Beets-Tan RGH, Fillion-Robin JC, Pieper S, Aerts HJWL. Computational Radiomics System to Decode the Radiographic Phenotype. Cancer Res. 2017 Nov 1;77(21):e104-e107. doi: 10.1158/0008-5472.CAN-17-0339.
PubMed 29092951Forghani R, De Man B, Gupta R. Dual-Energy Computed Tomography: Physical Principles, Approaches to Scanning, Usage, and Implementation: Part 1. Neuroimaging Clin N Am. 2017 Aug;27(3):371-384. doi: 10.1016/j.nic.2017.03.002.
PubMed 28711199Yeboah J, McClelland RL, Polonsky TS, Burke GL, Sibley CT, O'Leary D, Carr JJ, Goff DC, Greenland P, Herrington DM. Comparison of novel risk markers for improvement in cardiovascular risk assessment in intermediate-risk individuals. JAMA. 2012 Aug 22;308(8):788-95. doi: 10.1001/jama.2012.9624.
PubMed 22910756Erbel R, Mohlenkamp S, Moebus S, Schmermund A, Lehmann N, Stang A, Dragano N, Gronemeyer D, Seibel R, Kalsch H, Brocker-Preuss M, Mann K, Siegrist J, Jockel KH; Heinz Nixdorf Recall Study Investigative Group. Coronary risk stratification, discrimination, and reclassification improvement based on quantification of subclinical coronary atherosclerosis: the Heinz Nixdorf Recall study. J Am Coll Cardiol. 2010 Oct 19;56(17):1397-406. doi: 10.1016/j.jacc.2010.06.030.
PubMed 20946997Yamak D, Panse P, Pavlicek W, Boltz T, Akay M. Non-calcified coronary atherosclerotic plaque characterization by dual energy computed tomography. IEEE J Biomed Health Inform. 2014 May;18(3):939-45. doi: 10.1109/JBHI.2013.2295534.
PubMed 24808227Mandal SR, Bharati A, Haghighi RR, Arava S, Ray R, Jagia P, Sharma S, Chatterjee S, Tabin M, Sharma M, Sharma S, Kumar P. Non-invasive characterization of coronary artery atherosclerotic plaque using dual energy CT: Explanation in ex-vivo samples. Phys Med. 2018 Jan;45:52-58. doi: 10.1016/j.ejmp.2017.12.006. Epub 2017 Dec 19.
PubMed 29472090Haghighi RR, Chatterjee S, Tabin M, Sharma S, Jagia P, Ray R, Singh RP, Yadav R, Sharma M, Krishna K, Vani VC, Lakshmi R, Mandal SR, Kumar P, Arava S. DECT evaluation of noncalcified coronary artery plaque. Med Phys. 2015 Oct;42(10):5945-54. doi: 10.1118/1.4929935.
PubMed 26429269Obaid DR, Calvert PA, Gopalan D, Parker RA, West NE, Goddard M, Rudd JH, Bennett MR. Dual-energy computed tomography imaging to determine atherosclerotic plaque composition: a prospective study with tissue validation. J Cardiovasc Comput Tomogr. 2014 May-Jun;8(3):230-7. doi: 10.1016/j.jcct.2014.04.007. Epub 2014 May 2.
PubMed 24939072Tanami Y, Ikeda E, Jinzaki M, Satoh K, Nishiwaki Y, Yamada M, Okada Y, Kuribayashi S. Computed tomographic attenuation value of coronary atherosclerotic plaques with different tube voltage: an ex vivo study. J Comput Assist Tomogr. 2010 Jan;34(1):58-63. doi: 10.1097/RCT.0b013e3181b66c41.
PubMed 20118723Barreto M, Schoenhagen P, Nair A, Amatangelo S, Milite M, Obuchowski NA, Lieber ML, Halliburton SS. Potential of dual-energy computed tomography to characterize atherosclerotic plaque: ex vivo assessment of human coronary arteries in comparison to histology. J Cardiovasc Comput Tomogr. 2008 Jul-Aug;2(4):234-42. doi: 10.1016/j.jcct.2008.05.146. Epub 2008 Jun 12.
PubMed 19083956Narula J, Nakano M, Virmani R, Kolodgie FD, Petersen R, Newcomb R, Malik S, Fuster V, Finn AV. Histopathologic characteristics of atherosclerotic coronary disease and implications of the findings for the invasive and noninvasive detection of vulnerable plaques. J Am Coll Cardiol. 2013 Mar 12;61(10):1041-51. doi: 10.1016/j.jacc.2012.10.054.
PubMed 23473409Kalisz K, Halliburton S, Abbara S, Leipsic JA, Albrecht MH, Schoepf UJ, Rajiah P. Update on Cardiovascular Applications of Multienergy CT. Radiographics. 2017 Nov-Dec;37(7):1955-1974. doi: 10.1148/rg.2017170100.
PubMed 29131773Cademartiri F, Seitun S, Clemente A, La Grutta L, Toia P, Runza G, Midiri M, Maffei E. Myocardial blood flow quantification for evaluation of coronary artery disease by computed tomography. Cardiovasc Diagn Ther. 2017 Apr;7(2):129-150. doi: 10.21037/cdt.2017.03.22.
PubMed 28540209Johnson TR, Krauss B, Sedlmair M, Grasruck M, Bruder H, Morhard D, Fink C, Weckbach S, Lenhard M, Schmidt B, Flohr T, Reiser MF, Becker CR. Material differentiation by dual energy CT: initial experience. Eur Radiol. 2007 Jun;17(6):1510-7. doi: 10.1007/s00330-006-0517-6. Epub 2006 Dec 7.
PubMed 17151859Puchner SB, Liu T, Mayrhofer T, Truong QA, Lee H, Fleg JL, Nagurney JT, Udelson JE, Hoffmann U, Ferencik M. High-risk plaque detected on coronary CT angiography predicts acute coronary syndromes independent of significant stenosis in acute chest pain: results from the ROMICAT-II trial. J Am Coll Cardiol. 2014 Aug 19;64(7):684-92. doi: 10.1016/j.jacc.2014.05.039.
PubMed 25125300
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral CT Protocol Optimization for Atherosclerotic Plaque CharacterizatION
- ClinicalTrials.gov ID
- NCT06886958
- Acronym / sponsor ID
- SCORPION / 7/22
- Conditions
- Atherosclerotic Disease
- Keywords
- Atherosclerotic Plaque, Dual-Energy CT (DECT), Photon-Counting CT (PCCT), Radiomics, Cardiovascular Risk Stratification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS SYNLAB SDNUniversity, hospital or other
- Collaborators
- Fondazione Monasterio/CNR
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 20 Mar 2025 (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 SCORPION study (Spectral CT Protocol Optimization for Atherosclerotic Plaque Characterization) is a retrospective and prospective observational research project aimed at improving the diagnostic accuracy of dual-energy CT (DECT) and photon-counting CT (PCCT) in the characterization of atherosclerotic plaques in the coronary and carotid arteries. Given that cardiovascular diseases remain a leading cause of mortality despite advances in prevention and treatment, optimizing non-invasive imaging methods is crucial. CT Angiography (CTA) has become the gold standard for diagnosing coronary artery disease and carotid stenosis, but existing techniques require enhancement to improve plaque characterization, which is vital for risk stratification and patient management. While DECT has demonstrated potential in differentiating tissue types, its clinical adoption has been slow due to a lack of broad validation. This study seeks to establish a standardized imaging protocol that will provide more precise and reproducible plaque characterization.
The primary objective of the study is to develop a standardized method for characterizing atherosclerotic plaques using DECT based on retrospective datasets from Synlab. The first secondary objective is to validate this workflow with photon-counting CT data from an independent cohort at Fondazione Monasterio/CNR, ensuring the reliability of the technique across different imaging modalities. The second secondary objective involves defining an optimized DECT protocol using the energy spectrum of PCCT, ultimately refining imaging parameters for improved plaque assessment.
The study is structured into two phases. In the retrospective phase, data from fifty patients with critical stenosis (greater than 75% narrowing of the artery) who previously underwent DECT scans are analyzed. This step focuses on optimizing imaging parameters, segmentation techniques, and post-processing workflows. In the prospective phase, another cohort of fifty patients undergoes scanning with photon-counting CT to validate the workflow developed in the first phase. The results will inform the refinement of an optimized DECT protocol, translating the benefits of photon-counting technology into more widely available DECT scanners.
Patients included in the study must be at least sixty years old and have undergone DECT for cardiovascular imaging of the coronary or carotid arteries. The imaging process involves a third-generation dual-energy CT scanner (Somatom Force, Siemens) with high-resolution imaging settings, dual-energy tube voltages of 150 and 90 kV, ECG-gated acquisition, and the use of iodine contrast. The collected data is processed using various reconstruction techniques to extract quantitative imaging biomarkers, including total plaque volume, non-calcified and calcified plaque volumes, remodeling index, and degree of luminal stenosis. The study employs PyRadiomics, an open-source platform for radiomic feature extraction, to standardize data analysis and improve reproducibility.
The expected outcome of this research is an improved molecular characterization of atherosclerosis, leading to more accurate risk stratification and predictive models for cardiovascular events. By refining imaging techniques, the study aims to enhance diagnostic precision and minimize unnecessary hospitalizations, ultimately improving patient outcomes. Furthermore, establishing a standardized DECT protocol will allow for broader clinical adoption, making advanced plaque characterization more accessible in routine cardiovascular assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Imaging patiets | – | –Patients who have undergone DECT for cardiovascular imaging (coronary and/or carotid) or with critical stenosis |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 60 years of age performing a cardiovascular imaging examination
Key inclusion criteria (2 listed)
- Patients who have undergone DECT for cardiovascular imaging (coronary and/or carotid)
- Patients with critical stenosis (>75% diameter, coronary or carotid artery) aged > 60aa
Key exclusion criteria (4 listed)
- Patients negative for critical stenosis (<75% diameter) and/or imaging artefacts (e.g. due to movement, swallowing, or arrhythmias).
- Patients under 60 years of age
- Patients allergic to iodinated contrast medium (prospective phase)
- Patients with chronic renal insufficiency (prospective phase)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Imaging analyses
Time frame: 1 - 24 months
Extraction of numerical data from imaging for the generation of a reproducible and standardized method for characterising the various components of atherosclerotic plaques
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 20 Mar 2025.
- Background: PubMed 29092951van Griethuysen JJM, Fedorov A, Parmar C, Hosny A, Aucoin N, Narayan V, Beets-Tan RGH, Fillion-Robin JC, Pieper S, Aerts HJWL. Computational Radiomics System to Decode the Radiographic Phenotype. Cancer Res. 2017 Nov 1;77(21):e104-e107. doi: 10.1158/0008-5472.CAN-17-0339.
- Background: PubMed 28711199Forghani R, De Man B, Gupta R. Dual-Energy Computed Tomography: Physical Principles, Approaches to Scanning, Usage, and Implementation: Part 1. Neuroimaging Clin N Am. 2017 Aug;27(3):371-384. doi: 10.1016/j.nic.2017.03.002.
- Background: PubMed 22910756Yeboah J, McClelland RL, Polonsky TS, Burke GL, Sibley CT, O'Leary D, Carr JJ, Goff DC, Greenland P, Herrington DM. Comparison of novel risk markers for improvement in cardiovascular risk assessment in intermediate-risk individuals. JAMA. 2012 Aug 22;308(8):788-95. doi: 10.1001/jama.2012.9624.
- Background: PubMed 20946997Erbel R, Mohlenkamp S, Moebus S, Schmermund A, Lehmann N, Stang A, Dragano N, Gronemeyer D, Seibel R, Kalsch H, Brocker-Preuss M, Mann K, Siegrist J, Jockel KH; Heinz Nixdorf Recall Study Investigative Group. Coronary risk stratification, discrimination, and reclassification improvement based on quantification of subclinical coronary atherosclerosis: the Heinz Nixdorf Recall study. J Am Coll Cardiol. 2010 Oct 19;56(17):1397-406. doi: 10.1016/j.jacc.2010.06.030.
- Background: PubMed 24808227Yamak D, Panse P, Pavlicek W, Boltz T, Akay M. Non-calcified coronary atherosclerotic plaque characterization by dual energy computed tomography. IEEE J Biomed Health Inform. 2014 May;18(3):939-45. doi: 10.1109/JBHI.2013.2295534.
- Background: PubMed 29472090Mandal SR, Bharati A, Haghighi RR, Arava S, Ray R, Jagia P, Sharma S, Chatterjee S, Tabin M, Sharma M, Sharma S, Kumar P. Non-invasive characterization of coronary artery atherosclerotic plaque using dual energy CT: Explanation in ex-vivo samples. Phys Med. 2018 Jan;45:52-58. doi: 10.1016/j.ejmp.2017.12.006. Epub 2017 Dec 19.
- Background: PubMed 26429269Haghighi RR, Chatterjee S, Tabin M, Sharma S, Jagia P, Ray R, Singh RP, Yadav R, Sharma M, Krishna K, Vani VC, Lakshmi R, Mandal SR, Kumar P, Arava S. DECT evaluation of noncalcified coronary artery plaque. Med Phys. 2015 Oct;42(10):5945-54. doi: 10.1118/1.4929935.
- Background: PubMed 24939072Obaid DR, Calvert PA, Gopalan D, Parker RA, West NE, Goddard M, Rudd JH, Bennett MR. Dual-energy computed tomography imaging to determine atherosclerotic plaque composition: a prospective study with tissue validation. J Cardiovasc Comput Tomogr. 2014 May-Jun;8(3):230-7. doi: 10.1016/j.jcct.2014.04.007. Epub 2014 May 2.
- Background: PubMed 20118723Tanami Y, Ikeda E, Jinzaki M, Satoh K, Nishiwaki Y, Yamada M, Okada Y, Kuribayashi S. Computed tomographic attenuation value of coronary atherosclerotic plaques with different tube voltage: an ex vivo study. J Comput Assist Tomogr. 2010 Jan;34(1):58-63. doi: 10.1097/RCT.0b013e3181b66c41.
- Background: PubMed 19083956Barreto M, Schoenhagen P, Nair A, Amatangelo S, Milite M, Obuchowski NA, Lieber ML, Halliburton SS. Potential of dual-energy computed tomography to characterize atherosclerotic plaque: ex vivo assessment of human coronary arteries in comparison to histology. J Cardiovasc Comput Tomogr. 2008 Jul-Aug;2(4):234-42. doi: 10.1016/j.jcct.2008.05.146. Epub 2008 Jun 12.
- Background: PubMed 23473409Narula J, Nakano M, Virmani R, Kolodgie FD, Petersen R, Newcomb R, Malik S, Fuster V, Finn AV. Histopathologic characteristics of atherosclerotic coronary disease and implications of the findings for the invasive and noninvasive detection of vulnerable plaques. J Am Coll Cardiol. 2013 Mar 12;61(10):1041-51. doi: 10.1016/j.jacc.2012.10.054.
- Background: PubMed 29131773Kalisz K, Halliburton S, Abbara S, Leipsic JA, Albrecht MH, Schoepf UJ, Rajiah P. Update on Cardiovascular Applications of Multienergy CT. Radiographics. 2017 Nov-Dec;37(7):1955-1974. doi: 10.1148/rg.2017170100.
- 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.
Carlo Cavaliere, MD principal investigator
carlo.cavaliere@synlab.it
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 Atherosclerotic Disease, run by IRCCS SYNLAB SDN 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 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?
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?
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?
Imaging analyses (time frame: 1 - 24 months). 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 NCT06886958, which also lists 17 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 20 Mar 2025.