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NCT01583842 · ClinicalTrials.gov registry record · Early Phase 1
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
A Early Phase 1 study, sponsored by Miguel Pampaloni.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT01583842: Clinical Trial Early Phase 1 study, sponsored by Miguel Pampaloni.
NCT01583842 is a Early Phase 1 study that was terminated before completion, run by Miguel Pampaloni. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01583842, a Early Phase 1 study, was terminated before completion, sponsored by Miguel Pampaloni.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. After all eligibility criteria are met, patients will receive a diagnostic imaging dose of 124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent, planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.
Primary Outcome
Descriptive statistics for each organ dose obtained from the organ dosimetry data will be reported, to demonstrate organ dosimetry calculations are feasible and concordant with prior calculations in prior conjugate planar dosimetry imaging studies and our pre-clinical murine models
Interventions
- DRUG 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)
- DRUG 124I-MIBG (carrier added)
- PROCEDURE Positron Emission Tomography (PET) /Computerized tomography (CT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-04-09 |
| Est. Completion | 2021-02-25 |
| Phase | Early Phase 1 |
Why NCT01583842 stopped before completion
NCT01583842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) is the first listed.
NCT01583842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01583842 about?
NCT01583842 is a clinical study titled "124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study". This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently en...
What is the current status of trial NCT01583842?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2013-04-09. Estimated completion is 2021-02-25.
What interventions are being tested in trial NCT01583842?
The interventions under investigation include: 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) (DRUG), 124I-MIBG (carrier added) (DRUG), Positron Emission Tomography (PET) /Computerized tomography (CT) (PROCEDURE).
Who is sponsoring clinical trial NCT01583842?
This trial is sponsored by Miguel Pampaloni, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01583842's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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