GanglioneuroblastomaPhase 2NCT06858501
Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Florbenguane F18 in people with Ganglioneuroblastoma and Ganglioneuroblastoma, Nodular, run by Children's Oncology Group.
Trial summary
This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography [PET]/computed tomography [CT] or PET/magnetic resonance imaging [MRI]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, High Risk Neuroblastoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Florbenguane F18
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2026to 20 Dec 2028
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age at diagnosis.
- Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular, unfavorable subtype) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
- Patients must have high-risk neuroblastoma defined as one of the following:
- Any age with International Neuroblastoma Risk Group (INRG) stage L2 or M and MYCN amplification.
- Age ≥ 547 days and INRG stage M regardless of biologic features.
- Age ≥ 547 days and INRG stage L2 with unfavorable histology.
Show all 12Show fewer
- Patients must have newly diagnosed disease.
- Patients must have either measurable or evaluable disease by INRC.
- Patients observed or treated with a single cycle of chemotherapy per a low- or intermediate-risk neuroblastoma regimen (e.g. as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease, but subsequently found to meet high-risk criteria will be eligible. These patients must enroll prior to the start of high-risk therapy.
- Patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible.
- Patients initially recognized to have high-risk disease must enroll prior to or within the first week after starting high-risk induction chemotherapy.
- Induction therapy as per a standard high-risk neuroblastoma induction regimen (examples include ANBL1531 arm A, ANBL2131 arm A, or ANBL2131 arm B) must be planned for patients to be eligible for this study.
Who cannot join
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events of radiation. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) at least 48 hours prior to and following all imaging studies. Abstinence is an acceptable method of birth control.
- Norepinephrine transporter (NET)-dependent agents: Many medications are known to interfere with uptake of NET-dependent agents. Investigators should use caution when prescribing these medications for patients undergoing procedures on this study. Medications that are known to substantially interfere with uptake of NET-dependent agents should be held if possible, based on patient condition 24 hours prior to each 18F-MFBG scan. These agents can be resumed immediately after each 18F-MFBG scan is completed. Patients who are receiving medications that are known to significantly interfere with uptake of NET-dependent agents (primarily tricyclic antidepressants, psychostimulants, and antihypertensives) and for whom these medications cannot be safely withheld before the start of study procedures will not be eligible.
- The patient has a known or suspected history of significant allergic reaction or anaphylaxis to any components of the 18F-MFBG or 123I-MIBG imaging agents.
- Patients who will require sedation or anesthesia only for 18F-MFBG imaging.
- Note: Patients who need anesthesia will be required to have 18F-MFBG imaging combined with other scans or procedures necessary for clinical care (ex: MRI, bone marrow aspirate/biopsies, line placement).
- Patients will be able to enroll prior to baseline 123I-MIBG imaging. However, patients who have had their baseline standard of care 123I-MIBG imaging prior to enrollment who have known MIBG non-avid disease are not eligible.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
About this study
Official title: Concordance in Response Assessment Incorporating Meta-Iodobenzylguanidine (123I-MIBG) and Meta-[18F]Fluorobenzylguanidine (18F-MFBG, IND#146379, NSC#853868) Imaging in Neuroblastoma
This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography [PET]/computed tomography [CT] or PET/magnetic resonance imaging [MRI]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET/CT or PET/MRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET/CT or PET/MRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the concordance in International Neuroblastoma Response Criteria (INRC) response designations at the end of induction as assessed by iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) central reads in patients with high-risk stage L2 and stage M neuroblastoma.
SECONDARY OBJECTIVES:
- To describe individual metastatic lesion response using 123I-MIBG and 18F-MFBG imaging at diagnosis and end-induction.
II. To describe concordance in central Curie score between 123I-MIBG and 18F-MFBG imaging.
III. To describe concordance in end of induction response designations (poor end-of induction response versus [vs.] good end-of induction response) as assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy.
IV. To describe concordance as assessed by 123I-MIBG and 18F-MFBG in the INRC components of primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites in patients receiving high-risk therapy.
EXPLORATORY OBJECTIVES:
- To describe concordance in International Neuroblastoma Risk Group Staging System (INRGSS) stage as assessed by 123I-MIBG and 18F-MFBG.
II. To describe the natural history of discordant lesions detected only by 18F-MFBG and not by 123I-MIBG in patients with high-risk neuroblastoma, and to describe additional interventions undertaken (including additional imaging, biopsies, and/or additional therapies) based on identification of discordant lesions.
III. To describe the change in standardized uptake value (SUV) of the primary and metastatic lesions on 18F-MFBG scans from diagnosis to end of induction.
IV. To evaluate the patient/family experience with 123I-MIBG and 18F-MFBG imaging.
- To describe concordance between detection of disease using 123I-MIBG imaging (Curie score), 18F-MFBG imaging (Curie score) and the percentage of circulating tumor deoxyribonucleic acid (DNA) (as a continuous variable) testing during high-risk neuroblastoma therapy.
VI. To identify logistical barriers to successful imaging using 18F-MFBG. VII. To quantify inter-observer variability of Curie scores on 18F-MFBG and 123I-MIBG among central reviewers.
VIII. To describe acute toxicity of 18F-MFBG administration. IX. To estimate the progression free survival (PFS) and overall survival (OS) among eligible patients enrolled on the study.
OUTLINE:
Patients receive 18F-MFBG intravenously (IV) over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each standard of care (SOC) 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression). Patients may undergo blood sample collection throughout the study.
- Being tested
- Biospecimen Collection, Computed Tomography, Florbenguane F18, Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Ganglioneuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Florbenguane F18Radiation
Also called 18F meta-Fluoro Benzylguanidine, 18F-MFBG, [(18)F]-MFBG, Florbenguane (18F)
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo PET/MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT or PET/MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-MFBG) | Experimental | Patients receive 18F-MFBG IV over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each SOC 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression).
Patients may undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Florbenguane F18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in International Neuroblastoma Response Criteria (INRC) objective response measures
Will be estimated with 95% confidence intervals (CIs) using the unweighted kappa coefficient at each of the three time points.
Measured: Up to 105 days
Secondary outcomes (4)
Individual metastatic lesion response
Will be assessed using iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) imaging. Response will be summarized by number (percent [%]) of lesions stratified by imaging modality. A generalized linear mixed model will also estimate percent response by imaging modalities and compare response between modalities. The model will include fixed effects for modality, cumulative logit link function, multinomial distribution, and random effects for patient and lesion within patient.
Measured: Up to 105 days
Curie scores
Will estimate the correlation between Curie scores on both 123I-MIBG and 18F-MFBG imaging using Spearman rank correlation with a 95% CI.
Measured: Up to 3 years
Concordance in end of induction response
Will be measured as poor versus good. Will be assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy. Will be estimated by the kappa coefficient.
Measured: Up to 105 days
Concordance in 123I-MIBG and 18F-MFBG scans by INRC components
Will be assessed by primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites, in patients receiving high-risk therapy. Concordance will be estimated using Cohen's kappa.
Measured: Up to 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start22 Sep 2026 (estimated)
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Why it stopped: Other - Protocol moved to Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GanglioneuroblastomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tanya C Watt, Principal investigator, Pediatric Early Phase Clinical Trial Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858501
- Sponsor's protocol ID
- PEPN24N1
- Other IDs
- NCI-2025-00042, PEPN24N1, PEPN24N1, UM1CA228823
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance in Response Assessment Incorporating Meta-Iodobenzylguanidine (123I-MIBG) and Meta-[18F]Fluorobenzylguanidine (18F-MFBG, IND#146379, NSC#853868) Imaging in Neuroblastoma
- ClinicalTrials.gov ID
- NCT06858501
- Acronym / sponsor ID
- PEPN24N1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other - Protocol moved to Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Study start
- 22 Sep 2026 (estimated)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 5 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.
This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography [PET]/computed tomography [CT] or PET/magnetic resonance imaging [MRI]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET/CT or PET/MRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET/CT or PET/MRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.
Detailed description
PRIMARY OBJECTIVE:
- To estimate the concordance in International Neuroblastoma Response Criteria (INRC) response designations at the end of induction as assessed by iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) central reads in patients with high-risk stage L2 and stage M neuroblastoma.
SECONDARY OBJECTIVES:
- To describe individual metastatic lesion response using 123I-MIBG and 18F-MFBG imaging at diagnosis and end-induction.
II. To describe concordance in central Curie score between 123I-MIBG and 18F-MFBG imaging.
III. To describe concordance in end of induction response designations (poor end-of induction response versus [vs.] good end-of induction response) as assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy.
IV. To describe concordance as assessed by 123I-MIBG and 18F-MFBG in the INRC components of primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites in patients receiving high-risk therapy.
EXPLORATORY OBJECTIVES:
- To describe concordance in International Neuroblastoma Risk Group Staging System (INRGSS) stage as assessed by 123I-MIBG and 18F-MFBG.
II. To describe the natural history of discordant lesions detected only by 18F-MFBG and not by 123I-MIBG in patients with high-risk neuroblastoma, and to describe additional interventions undertaken (including additional imaging, biopsies, and/or additional therapies) based on identification of discordant lesions.
III. To describe the change in standardized uptake value (SUV) of the primary and metastatic lesions on 18F-MFBG scans from diagnosis to end of induction.
IV. To evaluate the patient/family experience with 123I-MIBG and 18F-MFBG imaging.
- To describe concordance between detection of disease using 123I-MIBG imaging (Curie score), 18F-MFBG imaging (Curie score) and the percentage of circulating tumor deoxyribonucleic acid (DNA) (as a continuous variable) testing during high-risk neuroblastoma therapy.
VI. To identify logistical barriers to successful imaging using 18F-MFBG. VII. To quantify inter-observer variability of Curie scores on 18F-MFBG and 123I-MIBG among central reviewers.
VIII. To describe acute toxicity of 18F-MFBG administration. IX. To estimate the progression free survival (PFS) and overall survival (OS) among eligible patients enrolled on the study.
OUTLINE:
Patients receive 18F-MFBG intravenously (IV) over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each standard of care (SOC) 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression). Patients may undergo blood sample collection throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-MFBG) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Radiation: Florbenguane F18, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Questionnaire AdministrationPatients receive 18F-MFBG IV over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each SOC 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression). Patients may undergo blood sample collection throughout the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Any age at diagnosis.
- Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular, unfavorable subtype) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
- Patients must have high-risk neuroblastoma defined as one of the following:
- Patients must have newly diagnosed disease.
- Patients must have either measurable or evaluable disease by INRC.
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events of radiation. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) at least 48 hours prior to and following all imaging studies. Abstinence is an acceptable method of birth control.
- Norepinephrine transporter (NET)-dependent agents: Many medications are known to interfere with uptake of NET-dependent agents. Investigators should use caution when prescribing these medications for patients undergoing procedures on this study. Medications that are known to substantially interfere with uptake of NET-dependent agents should be held if possible, based on patient condition 24 hours prior to each 18F-MFBG scan. These agents can be resumed immediately after each 18F-MFBG scan is completed. Patients who are receiving medications that are known to significantly interfere with uptake of NET-dependent agents (primarily tricyclic antidepressants, psychostimulants, and antihypertensives) and for whom these medications cannot be safely withheld before the start of study procedures will not be eligible.
- The patient has a known or suspected history of significant allergic reaction or anaphylaxis to any components of the 18F-MFBG or 123I-MIBG imaging agents.
- Patients who will require sedation or anesthesia only for 18F-MFBG imaging.
- Patients will be able to enroll prior to baseline 123I-MIBG imaging. However, patients who have had their baseline standard of care 123I-MIBG imaging prior to enrollment who have known MIBG non-avid disease are not eligible.
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Diagnostic (18F-MFBG) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (18F-MFBG) |
| Florbenguane F18Also: 18F meta-Fluoro Benzylguanidine, 18F-MFBG, [(18)F]-MFBG, Florbenguane (18F)Given IV | Radiation | Diagnostic (18F-MFBG) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo PET/MRI | Procedure or surgery | Diagnostic (18F-MFBG) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT or PET/MRI | Procedure or surgery | Diagnostic (18F-MFBG) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (18F-MFBG) |
Primary outcome
Concordance in International Neuroblastoma Response Criteria (INRC) objective response measures
Time frame: Up to 105 days
Will be estimated with 95% confidence intervals (CIs) using the unweighted kappa coefficient at each of the three time points.
4 secondary outcomes
Individual metastatic lesion response
Time frame: Up to 105 days
Curie scores
Time frame: Up to 3 years
Concordance in end of induction response
Time frame: Up to 105 days
Concordance in 123I-MIBG and 18F-MFBG scans by INRC components
Time frame: Up to 105 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Tanya C Watt principal investigator
Pediatric Early Phase Clinical Trial Network
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Florbenguane F18 in people with Ganglioneuroblastoma and Ganglioneuroblastoma, Nodular, run by Children's Oncology Group.
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 12 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Concordance in International Neuroblastoma Response Criteria (INRC) objective response measures (time frame: Up to 105 days). 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 16 Sep 2026.