Hepatocellular CarcinomaPET-HCC01NCT04391348
Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC
A study testing PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 28 Apr 2023
- 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
- Patients> 18 years old
- First diagnosis of HCC (no previous treatments received)
- Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver
- BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging
- Will be able to have a PET scanner within 4 weeks after the inclusion visit
- Ability to stay 20 minutes longer for PET-CT scans
Show all 9Show fewer
- Need for oral, intra-uterine or mechanical contraception for women of childbearing age
- Written consent for participation in the study
- Having medical insurance coverage
Who cannot join
- Patients classified BCLC stage 0 (single HCC less than 2 cm)
- Patients classified as BCLC stage C with extrahepatic metastases
- Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation
- Uncontrolled diabetes (defined by blood glucose> 1.7 g / L at the time of inclusion)
- Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients
- Creatinine clearance <40 mL / min
Show all 12Show fewer
- Contraindication to MRI: pacemaker or implantable cardiac defibrillator not compatible with MRI, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip, intraocular or cerebral metallic foreign bodies, insulin pump
- Pregnant or lactating woman
- Patient under tutorship or curatorship or safeguard of justice
- Known allergy to iodine
- Patient deprived of liberty by judicial or administrative decision
- Patients with care "State Medical Aid"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma
The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the leading causes of death from cancer worldwide, developing on cirrhosis in 90% of cases. The prognosis of patients with HCC remains poor with an overall survival of around 10% at 5 years for all tumor stages combined. The diagnosis of HCC relies on non-invasive conventional imaging criteria (computed tomography [CT] and/or magnetic resonance imaging [MRI]) and/or histology. Conventional imaging (liver CT and/or MRI and lung CT) enables HCC staging according to the Barcelona Clinical Liver Cancer (BCLC) system, linking each stage to therapeutic modalities. Accurate staging with reliable imaging methods is therefore crucial to determine the best treatment strategy. The principal objective is to demonstrate that the identification of new tumor lesions by an experimental procedure combining 18F-FDG and 18F-Fluorocholine PET-CT scans in patients with HCC, modifies the initially planned therapeutic strategy of a curative treatment palliative treatment, from locoregional palliative treatment to systemic palliative treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine
- Keywords
- Positron Emission Tomography, 18F-FDG, 18 F-Fluorocholine
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholineRadiation
Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
| Study group | Role | What they receive |
|---|---|---|
| PET-TDM | Experimental | PET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine Receives: Radiation: PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.
Measured: through multidisciplinary concertation meeting an average of 3 days
Secondary outcomes (6)
Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
The proportion of patients for whom curative treatment initially planned on the basis of conventional imaging has been modified for loco-regional or systemic palliative treatment by the experimental procedure (PET-TDMs at 18F-FDG and 18F-Fluorocholine).
Measured: through multidisciplinary concertation meeting an average of 3 days
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
The proportion of modification of the tumor status to a more advanced status in the BCLC classification using PET/CT using 18F-FDG alone, 18F-Fluorocholine alone and then the combination of both in association with conventional imaging compared to conventional imaging alone
Measured: through multidisciplinary concertation meeting an average of 3 days
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
The proportion of patients with an additional tumor lesion detected by 18F-FDG-PET alone, with 18F-Fluorocholine alone and then the combination of both, whose tumor nature is confirmed histologically or by imaging follow-up
Measured: through multidisciplinary concertation meeting an average of 3 days
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
The proportion of new intrahepatic and/or extrahepatic lesions detected by PET-TDMs at 18F-FDG and 18F-Fluorocholine and confirmed as HCC on histology or by imaging follow-up
Measured: through multidisciplinary concertation meeting an average of 3 days
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
The (incremental) cost-effectiveness ratio of 18F-FDG and 18F-Fluorocholine PET-CTs associated with conventional imaging versus conventional imaging alone
Measured: through multidisciplinary concertation meeting an average of 3 days
Number of patients who had an additional examination proposed by the MCM (multidisciplinary consultation meeting) following the PET-TDMs performed
The number of patients who have had an additional complementary examination (biopsy or new imaging for example) proposed by the MCM following 18F-FDG and 18F-Fluorocholine PET-CT scans will be collected prospectively
Measured: through multidisciplinary concertation meeting an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start17 Jul 2020
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean Charles NAULT, PhD, Principal investigator, Assistance Publique - Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391348
- Sponsor's protocol ID
- APHP180570
- Other IDs
- 2019-A02031-56
- Acronym
- PET-HCC01
- Status last verified
- Nov 2023
- First submitted
- 4 May 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
PubMed 29031662Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.
PubMed 28176349Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.
PubMed 26202754Nault JC, Boubaya M, Wartski M, Dohan A, Pol S, Pop G, Soussan M, Sutter O, Costentin C, Roux J, Sengel C, Lequoy M, Montravers F, Menu Y, Pageaux GP, Goulart DM, Guiu B, Luciani A, Nahon P, Dioguardi Burgio M, Wagner M, Maksud P, Mule S, Allaire M, Sidali S, Coilly A, Besson FL, Lewin M, Regnault H, Hollande C, Amaddeo G, Ronot M, Ganne-Carrie N, Itti E, Bloch-Queyrat C, Levy V, Lebtahi R, Chalaye J, Bouattour M. [18F]fluorodeoxyglucose and [18F]fluorocholine PET-CT for staging optimisation and treatment modification in hepatocellular carcinoma (PET-HCC01): a prospective multicentre study. Lancet Gastroenterol Hepatol. 2025 Apr;10(4):306-314. doi: 10.1016/S2468-1253(25)00011-1. Epub 2025 Feb 20.
PubMed 39987937
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04391348
- Acronym / sponsor ID
- PET-HCC01 / APHP180570
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Positron Emission Tomography, 18F-FDG, 18 F-Fluorocholine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 18 May 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 objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.
Detailed description
Hepatocellular carcinoma (HCC) is one of the leading causes of death from cancer worldwide, developing on cirrhosis in 90% of cases. The prognosis of patients with HCC remains poor with an overall survival of around 10% at 5 years for all tumor stages combined. The diagnosis of HCC relies on non-invasive conventional imaging criteria (computed tomography [CT] and/or magnetic resonance imaging [MRI]) and/or histology. Conventional imaging (liver CT and/or MRI and lung CT) enables HCC staging according to the Barcelona Clinical Liver Cancer (BCLC) system, linking each stage to therapeutic modalities. Accurate staging with reliable imaging methods is therefore crucial to determine the best treatment strategy. The principal objective is to demonstrate that the identification of new tumor lesions by an experimental procedure combining 18F-FDG and 18F-Fluorocholine PET-CT scans in patients with HCC, modifies the initially planned therapeutic strategy of a curative treatment palliative treatment, from locoregional palliative treatment to systemic palliative treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| PET-TDM | Experimental | Radiation: PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholinePET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients> 18 years old
- First diagnosis of HCC (no previous treatments received)
- Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver
- BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging
- Will be able to have a PET scanner within 4 weeks after the inclusion visit
Key exclusion criteria (12 listed)
- Patients classified BCLC stage 0 (single HCC less than 2 cm)
- Patients classified as BCLC stage C with extrahepatic metastases
- Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation
- Uncontrolled diabetes (defined by blood glucose> 1.7 g / L at the time of inclusion)
- Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients
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-TDM with 18F-FDG + PET-TDM with 18F-fluorocholineExperimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine | Radiation | PET-TDM |
Primary outcome
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
Time frame: through multidisciplinary concertation meeting an average of 3 days
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.
6 secondary outcomes
Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
Time frame: through multidisciplinary concertation meeting an average of 3 days
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
Time frame: through multidisciplinary concertation meeting an average of 3 days
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
Time frame: through multidisciplinary concertation meeting an average of 3 days
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
Time frame: through multidisciplinary concertation meeting an average of 3 days
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
Time frame: through multidisciplinary concertation meeting an average of 3 days
Number of patients who had an additional examination proposed by the MCM (multidisciplinary consultation meeting) following the PET-TDMs performed
Time frame: through multidisciplinary concertation meeting an average of 3 days
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 18 Nov 2023.
- Background: PubMed 29031662Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
- Background: PubMed 28176349Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.
- Background: PubMed 26202754Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.
- Derived from this study: PubMed 39987937Nault JC, Boubaya M, Wartski M, Dohan A, Pol S, Pop G, Soussan M, Sutter O, Costentin C, Roux J, Sengel C, Lequoy M, Montravers F, Menu Y, Pageaux GP, Goulart DM, Guiu B, Luciani A, Nahon P, Dioguardi Burgio M, Wagner M, Maksud P, Mule S, Allaire M, Sidali S, Coilly A, Besson FL, Lewin M, Regnault H, Hollande C, Amaddeo G, Ronot M, Ganne-Carrie N, Itti E, Bloch-Queyrat C, Levy V, Lebtahi R, Chalaye J, Bouattour M. [18F]fluorodeoxyglucose and [18F]fluorocholine PET-CT for staging optimisation and treatment modification in hepatocellular carcinoma (PET-HCC01): a prospective multicentre study. Lancet Gastroenterol Hepatol. 2025 Apr;10(4):306-314. doi: 10.1016/S2468-1253(25)00011-1. Epub 2025 Feb 20.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Jean Charles NAULT, PhD principal investigator
Assistance Publique - Hôpitaux Paris
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-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 12 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 18 Nov 2023. 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?
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy (time frame: through multidisciplinary concertation meeting an average of 3 days). 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 NCT04391348, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.