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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 is a Early Phase 1 study that was terminated before completion, run by Miguel Pampaloni. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01583842
The ClinicalTrials.gov registry entry for NCT01583842 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Miguel Pampaloni, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) is the first listed.
NCT01583842 reports 0 study locations.
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.
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