Cardiac AmyloidosisCAPRINCT03616496
Assessment of 18F-Florbetaben Whole-body PET for the Detection of Cardiac and Extracardiac Sites of Amyloid Deposits
A study testing Neuraceq PET/CT imaging in people with Cardiac Amyloidosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Although being classified as a rare disease, cardiac amyloidosis constitutes an increasing cause of heart failure, which is often overlooked and thus poorly managed. Amyloidosis involves deposits of light chain immunoglobulins in the immunoglobulin light chain amyloidosis (AL) type, but it may also be of a hereditary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Neuraceq PET/CT imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 10 Feb 2025
- 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
- For all study participants
- Person affiliated to or beneficiary of, a social security plan
- Person informed about study organization and having signed the informed consent
- For ATTR amyloidosis patients:
- left ventricular concentric hypertrophy with a diastolic septal thickness ≥ 15 mm at echography (as defined by the current distribution of this parameter in the ATTR patients involved in a French national cohort of the Henri Mondor Hospital),
- clearly positive bone scan (> mild cardiac uptake) and/or concordant results at pathology of cardiac or extra-cardiac sites (Congo red-positive deposits under crossed polarized light and immunohistochemical staining for transthyretin).
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- For AL amyloidosis patients:
- left ventricular concentric hypertrophy with a diastolic septal thickness ≥ 13 mm at echography (as defined by the current distribution of this parameter in the AL patients involved in the French national cohort of the Henri Mondor Hospital),
- significant cardiac disease evidenced by an increase in plasma N-Terminal ProBNP (or BNP) and/or in troponin T (or I), corresponding to a Mayo clinic score ≥ 2 ,
- concordant results at pathology of cardiac or extra-cardiac sites (Congo red-positive deposits under crossed polarized light and immunohistochemical staining for κ and λ immunoglobulin light chains).
- For control subjects:
- History of surgical or Transcatheter Aortic Valve Implantation (TAVI)treatment of aortic stenosis
- Matching with amyloidosis patients according to gender and age (± 5 years).
- Cardiac hypertrophy with a diastolic septal thickness ≥ 15 mm at echography when matching with an ATTR patient and ≥ 13 mm when matching with an AL patient.
Who cannot join
- Known allergy to the active substance and to any excipient for 18F-Florbetaben or for the bone scintigraphy radiotracer (99mTc-MDP)
- Pregnancy, breastfeeding and woman of childbearing age without effective contraception
- Person referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty for judicial or administrative decision
- Person under psychiatric care
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- Person admitted to health or social institution for other reasons than research
- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)
- Adult person incapable of giving consent and not under legal protection
- No obvious cause of cardiac disease except for mild to moderate hypertension in all study subjects, for cardiac amyloidosis in the amyloidosis groups and for aortic stenosis in the control group
- Impossibility of performing 18F-Florbetaben PET (agitated, confused patient, etc.).
- Sever left ventricular dysfunction with an ejection fraction ≤ 35%
- Severe hepatic or renal failure.
- For control patients only: monoclonal gammopathy on a previous protein electrophoresis or ≥ mild cardiac uptake on a previous bone scintigraphy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of 18F-Florbetaben Whole-body PET Imaging for the Comprehensive Detection of Cardiac and Extracardiac Sites of Amyloid Deposits
Although being classified as a rare disease, cardiac amyloidosis constitutes an increasing cause of heart failure, which is often overlooked and thus poorly managed. Amyloidosis involves deposits of light chain immunoglobulins in the immunoglobulin light chain amyloidosis (AL) type, but it may also be of a hereditary type in mutated transthyretin amyloidosis (ATTRm) or of a senile type in wildtype transthyretin forms (ATTRwt).
Myocardial biopsy remains a gold standard for definitive diagnosis but it is a traumatic technique which only provides information on a limited number of sampled sites.
Read more
Useful but not fully specific signs of cardiac amyloidosis may also be provided by Magnetic Resonance Imaging or MRI (delayed retention imaging) and echocardiography (longitudinal strain pattern).
Notwithstanding the above, relatively specific markers of amyloid plaques are now available in Positron Emission Tomography (PET). These markers are primarily fluorinated tracers which have been developed for the diagnosis of Alzheimer's disease. Two of these have already been the subject of feasibility studies in the setting of cardiac amyloidosis diagnosis, on a maximum of 10 amyloidosis patients but with very favorable results.
The hypothesis is that one of these two tracers, Florbetaben labelled with Fluorine-18-Florbetaben (18F-Florbetaben) used in the study, has sufficiently strong and prolonged binding kinetics at the level of the amyloid plaques to allow: (i) achieving whole-body PET recordings and thus, (ii) identifying not only cardiac amyloidosis but also extracardiac binding sites, particularly those readily accessible to biopsy sampling. This hypothesis has been strengthened by a recent case report illustrating the ability of whole-body florbetaben-PET to image not only cardiac but also extra-cardiac sites of amyloid deposits (Clin Nucl Med. 2017;42(1):50-3).
Read the detailed description
In addition, distinctive imaging patterns pointing to amyloidosis may also be documented by other imaging techniques although insufficiently specific (e.g. decreased cardiac uptake of metaiodobenzylguanidine (MIBG), evocative pattern of delayed retention at Magnetic Resonance Imaging (MRI) or at strain echocardiography. Specific markers of amyloid plaques have been developed for the diagnosis of Alzheimer's disease and were initially labeled with carbon-11 and more recently, with fluor-18. Most of these markers have already been the subject of feasibility studies on limited numbers of amyloidosis patients (max 10) but with favorable results. In a previous pilot study, one of these tracers, the 18F-Florbetaben used in the present study-protocol, exhibited particularly slow kinetics, with differences in cardiac uptake between patients and controls still being documented as late as 80-min following injection. This uptake was also found to be somewhat lower in the 5 ATTR patients comparatively to the 5 AL patients. It may be hypothesized that 18F-Florbetaben has sufficiently slow and prolonged binding kinetics at the level of the amyloid plaques to allow: (i) achieving whole-body PET recordings with current recording times of 20 to 30 min and thus, (ii) identifying not only cardiac amyloidosis but also extracardiac binding sites, particularly those readily accessible to biopsy sampling. This hypothesis has just been strengthened by a recent case report, published by investigators involved in the present project and illustrating the ability of whole-body 18F-Florbetaben-PET to image not only cardiac but also various extracardiac sites of amyloid deposits.The proposed study would be the first in which the sample size would be sufficient to provide a credible assessment of the ability of PET, using an amyloid plaque tracer, to identify cardiac amyloidosis and with a possible separate analysis of ATTR and AL forms. Moreover, it would also constitute the first study involving an extensive use of whole-body PET imaging to assess the benefit of amyloidosis detection, not only at the cardiac level, but also at peripheral sites, especially those accessible for biopsy (tongue, rectum, salivary glands, carpal tunnel, liver, subcutaneous tissue, thyroid,...).
Being able to confirm or invalidate the diagnosis of cardiac amyloidosis in a non-invasive manner and by guiding biopsy sampling to the most active extracardiac sites would be a major step forward for these patients whose diagnosis is most often established too late, i.e. at an advanced stage of heart failure.
In the longer term,18F-Florbetaben whole-body PET could be helpful for the non-invasive monitoring of the evolution of cardiac as well as extracardiac sites of amyloid deposits under dedicated specific treatments (chemotherapies in AL forms and specific treatments currently under investigation for the AL forms). Such monitoring is still impossible today.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Neuraceq PET/CT imaging
- Keywords
- PET imaging, Cardiac Amyloidosis, Florbetaben, Heart failure, Cardiology
- Medical subject headings
- Amyloid Neuropathies, Familial, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraceq PET/CT imagingDrug
Also called Bone scintigraphy, Blood and urine sampling for protein electrophoresis
PET/CT with Neuraceq injection, blood and urine sampling for protein electrophoresis, bone scintigraphy for the three arm (if the exams are present in the patient's medical record and are less than 3 months old, they do not need to be repeated
| Study group | Role | What they receive |
|---|---|---|
| ATTR amyloidosis patients | Experimental | Intervention by this arm: PET/CT with injection of Neuraceq [4 MegaBecquerel /Kilogram (MBq/kg)], blood and urine sampling for protein electrophoresis, bone scintigraphy Receives: Drug: Neuraceq PET/CT imaging |
| AL amyloidosis patients | Experimental | Intervention by this arm: PET with injection of Neuraceq (4 MBq/kg), blood and urine sampling for protein electrophoresis, bone scintigraphy Receives: Drug: Neuraceq PET/CT imaging |
| Control subjects with aortic stenosis | Active comparator | Intervention by this arm: PET with injection of Neuraceq (4 MBq/kg), blood and urine sampling for protein electrophoresis, bone scintigraphy.
Control subjects are patients with aortic stenosis and left ventricular hypertrophy treated by surgery or by Transcatheter Aortic Valve Implantation (TAVI) Receives: Drug: Neuraceq PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitive diagnosis of cardiac ATTR- or AL-amyloidosis upon current diagnosis standard (including cardiac or extracardiac biopsies),
The diagnosis will be made with standard parameters (including cardiac or extracardiac biopsies), Importantly, a " control " population, including patients with left ventricular hypertrophy definitively unrelated to amyloidosis (even for low to mild forms) will be added for the analysis (this hypertrophy is mandatory for reaching a comparable partial volume effect than with amyloidosis patients when recording myocardial PET activity).
Measured: upon 24 months
Secondary outcomes (5)
To assess the diagnostic performance of whole-body PET/CT recordings, as reported in the main objective, to identify AL and ATTR amyloidosis individually.
Identical to the primary endpoint, except that the analyses will be planned separately for AL and ATTR amyloidosis.
Measured: upon 24 months
To determine whether (18)F-florbetaben whole-body PET/CT images can reveal extracardiac areas with increased activity
Areas of abnormal (18)F-florbetaben uptake will be studied on whole-body PET/CT
Measured: upon 24 months
To compare the cardiac kinetics of (18)F-florbetaben and an early myocardial retention index, within the first 10 minutes following injection, between patients with cardiac amyloidosis and the control population
Comparative analysis of the evolution of myocardial SUV (Standard Uptake Value) and TBRtarget-to-blood pool ratio) ( values and of an early myocardial retention index during the 10 minutes post-injection period in patients and controls
Measured: upon 24 month
To determine whether most patients with true-positive MRI for cardiac amyloidosis
the comparison of the analysis will be made with myocardial tissue-to-background ratios (TBR) where the activities measured in SUV will be expressed relative to a mean blood background activity.
Measured: upon 24 month
To assess the intra- and inter-observer agreements for the analysis of (18)F-florbetaben whole-body PET/CT images.
Intra-observer and inter-observer reproducibility measurements of SUV and TBR values obtained at cardiac and extracardiac sites from whole-body PET / CT images of 20 patients with amyloidosis (10 with Type AL and 10 with an ATTR type).
Measured: upon 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start6 Jun 2019
- Primary completion30 Jan 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Yves MARIE, Central Hospital, Nancy, France
- Investigators
- Pierre-Yves MARIE, MD,PhD, Principal investigator, CHRU de NANCY BRABOIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616496
- Sponsor's protocol ID
- 2018-004054-24
- Other IDs
- 2018
- Acronym
- CAPRI
- Status last verified
- Feb 2025
- First submitted
- 27 Jul 2018
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 18F-Florbetaben Whole-body PET Imaging for the Comprehensive Detection of Cardiac and Extracardiac Sites of Amyloid Deposits
- ClinicalTrials.gov ID
- NCT03616496
- Acronym / sponsor ID
- CAPRI / 2018-004054-24
- Conditions
- Cardiac Amyloidosis
- Keywords
- PET imaging, Cardiac Amyloidosis, Florbetaben, Heart failure, Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 6 Aug 2018 (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.
Although being classified as a rare disease, cardiac amyloidosis constitutes an increasing cause of heart failure, which is often overlooked and thus poorly managed. Amyloidosis involves deposits of light chain immunoglobulins in the immunoglobulin light chain amyloidosis (AL) type, but it may also be of a hereditary type in mutated transthyretin amyloidosis (ATTRm) or of a senile type in wildtype transthyretin forms (ATTRwt).
Myocardial biopsy remains a gold standard for definitive diagnosis but it is a traumatic technique which only provides information on a limited number of sampled sites.
Useful but not fully specific signs of cardiac amyloidosis may also be provided by Magnetic Resonance Imaging or MRI (delayed retention imaging) and echocardiography (longitudinal strain pattern).
Notwithstanding the above, relatively specific markers of amyloid plaques are now available in Positron Emission Tomography (PET). These markers are primarily fluorinated tracers which have been developed for the diagnosis of Alzheimer's disease. Two of these have already been the subject of feasibility studies in the setting of cardiac amyloidosis diagnosis, on a maximum of 10 amyloidosis patients but with very favorable results.
The hypothesis is that one of these two tracers, Florbetaben labelled with Fluorine-18-Florbetaben (18F-Florbetaben) used in the study, has sufficiently strong and prolonged binding kinetics at the level of the amyloid plaques to allow: (i) achieving whole-body PET recordings and thus, (ii) identifying not only cardiac amyloidosis but also extracardiac binding sites, particularly those readily accessible to biopsy sampling. This hypothesis has been strengthened by a recent case report illustrating the ability of whole-body florbetaben-PET to image not only cardiac but also extra-cardiac sites of amyloid deposits (Clin Nucl Med. 2017;42(1):50-3).
Detailed description
In addition, distinctive imaging patterns pointing to amyloidosis may also be documented by other imaging techniques although insufficiently specific (e.g. decreased cardiac uptake of metaiodobenzylguanidine (MIBG), evocative pattern of delayed retention at Magnetic Resonance Imaging (MRI) or at strain echocardiography. Specific markers of amyloid plaques have been developed for the diagnosis of Alzheimer's disease and were initially labeled with carbon-11 and more recently, with fluor-18. Most of these markers have already been the subject of feasibility studies on limited numbers of amyloidosis patients (max 10) but with favorable results. In a previous pilot study, one of these tracers, the 18F-Florbetaben used in the present study-protocol, exhibited particularly slow kinetics, with differences in cardiac uptake between patients and controls still being documented as late as 80-min following injection. This uptake was also found to be somewhat lower in the 5 ATTR patients comparatively to the 5 AL patients. It may be hypothesized that 18F-Florbetaben has sufficiently slow and prolonged binding kinetics at the level of the amyloid plaques to allow: (i) achieving whole-body PET recordings with current recording times of 20 to 30 min and thus, (ii) identifying not only cardiac amyloidosis but also extracardiac binding sites, particularly those readily accessible to biopsy sampling. This hypothesis has just been strengthened by a recent case report, published by investigators involved in the present project and illustrating the ability of whole-body 18F-Florbetaben-PET to image not only cardiac but also various extracardiac sites of amyloid deposits.The proposed study would be the first in which the sample size would be sufficient to provide a credible assessment of the ability of PET, using an amyloid plaque tracer, to identify cardiac amyloidosis and with a possible separate analysis of ATTR and AL forms. Moreover, it would also constitute the first study involving an extensive use of whole-body PET imaging to assess the benefit of amyloidosis detection, not only at the cardiac level, but also at peripheral sites, especially those accessible for biopsy (tongue, rectum, salivary glands, carpal tunnel, liver, subcutaneous tissue, thyroid,...).
Being able to confirm or invalidate the diagnosis of cardiac amyloidosis in a non-invasive manner and by guiding biopsy sampling to the most active extracardiac sites would be a major step forward for these patients whose diagnosis is most often established too late, i.e. at an advanced stage of heart failure.
In the longer term,18F-Florbetaben whole-body PET could be helpful for the non-invasive monitoring of the evolution of cardiac as well as extracardiac sites of amyloid deposits under dedicated specific treatments (chemotherapies in AL forms and specific treatments currently under investigation for the AL forms). Such monitoring is still impossible today.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATTR amyloidosis patients | Experimental | Drug: Neuraceq PET/CT imagingIntervention by this arm: PET/CT with injection of Neuraceq [4 MegaBecquerel /Kilogram (MBq/kg)], blood and urine sampling for protein electrophoresis, bone scintigraphy |
| AL amyloidosis patients | Experimental | Drug: Neuraceq PET/CT imagingIntervention by this arm: PET with injection of Neuraceq (4 MBq/kg), blood and urine sampling for protein electrophoresis, bone scintigraphy |
| Control subjects with aortic stenosis | Active comparator | Drug: Neuraceq PET/CT imagingIntervention by this arm: PET with injection of Neuraceq (4 MBq/kg), blood and urine sampling for protein electrophoresis, bone scintigraphy. Control subjects are patients with aortic stenosis and left ventricular hypertrophy treated by surgery or by Transcatheter Aortic Valve Implantation (TAVI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For all study participants
- For ATTR amyloidosis patients:
- For AL amyloidosis patients:
- For control subjects:
Key exclusion criteria (15 listed)
- Known allergy to the active substance and to any excipient for 18F-Florbetaben or for the bone scintigraphy radiotracer (99mTc-MDP)
- Pregnancy, breastfeeding and woman of childbearing age without effective contraception
- Person referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
- No obvious cause of cardiac disease except for mild to moderate hypertension in all study subjects, for cardiac amyloidosis in the amyloidosis groups and for aortic stenosis in the control group
- Impossibility of performing 18F-Florbetaben PET (agitated, confused patient, etc.).
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 |
|---|---|---|
| Neuraceq PET/CT imagingAlso: Bone scintigraphy, Blood and urine sampling for protein electrophoresisPET/CT with Neuraceq injection, blood and urine sampling for protein electrophoresis, bone scintigraphy for the three arm (if the exams are present in the patient's medical record and are less than 3 months old, they do not need to be repeated | Drug | AL amyloidosis patients, ATTR amyloidosis patients, Control subjects with aortic stenosis |
Primary outcome
Definitive diagnosis of cardiac ATTR- or AL-amyloidosis upon current diagnosis standard (including cardiac or extracardiac biopsies),
Time frame: upon 24 months
The diagnosis will be made with standard parameters (including cardiac or extracardiac biopsies), Importantly, a " control " population, including patients with left ventricular hypertrophy definitively unrelated to amyloidosis (even for low to mild forms) will be added for the analysis (this hypertrophy is mandatory for reaching a comparable partial volume effect than with amyloidosis patients when recording myocardial PET activity).
5 secondary outcomes
To assess the diagnostic performance of whole-body PET/CT recordings, as reported in the main objective, to identify AL and ATTR amyloidosis individually.
Time frame: upon 24 months
To determine whether (18)F-florbetaben whole-body PET/CT images can reveal extracardiac areas with increased activity
Time frame: upon 24 months
To compare the cardiac kinetics of (18)F-florbetaben and an early myocardial retention index, within the first 10 minutes following injection, between patients with cardiac amyloidosis and the control population
Time frame: upon 24 month
To determine whether most patients with true-positive MRI for cardiac amyloidosis
Time frame: upon 24 month
To assess the intra- and inter-observer agreements for the analysis of (18)F-florbetaben whole-body PET/CT images.
Time frame: upon 24 month
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 11 Feb 2025.
- 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.
Pierre-Yves MARIE, MD,PhD principal investigator
CHRU de NANCY BRABOIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuraceq PET/CT imaging in people with Cardiac Amyloidosis, run by Central Hospital, Nancy, France at 1 site in France.
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 14 inclusion and 15 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 11 Feb 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 France. 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?
Definitive diagnosis of cardiac ATTR- or AL-amyloidosis upon current diagnosis standard (including cardiac or extracardiac biopsies), (time frame: upon 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.