Clinical trial · Interventional
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) | Drug | — | UNRESOLVED |
| 124I-MIBG (carrier added) | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) /Computerized tomography (CT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 124I-MIBG no-carrier added
- description
- Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
- interventionNames
- Drug: 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)
- Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)
- type
- EXPERIMENTAL
- label
- 124I-MIBG carrier added
- description
- Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
- interventionNames
- Drug: 124I-MIBG (carrier added)
- Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be \>/= 3 years of age and able to cooperate for the PET CT scan when registered on study. * Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites. * Recurrent/progressive disease at any time. Biopsy is not required, even if there is a partial response to intervening therapy or * Refractory disease (i.e. less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy). No biopsy is required for eligibility for this study. * 123I-MIBG Uptake: Patients must have MIBG evaluable disease which is defined as evidence of uptake into tumor at one site within 4 weeks prior to entry on study and subsequent to any intervening therapy. * Patients must meet eligibility criteria for 131I-MIBG therapy in order to participate in the dosimetry portion. * All post-menarchal females must have a negative beta-Human Chorionic Gonadotropin (hCG) within 2 weeks prior to receiving the dose of 124I-MIBG. Males and females of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus. Imaging only cohort: \- Patients with high-risk neuroblastoma are eligible at any time (during initial treatment or during treatment of relapsed/refractory disease) as long as they meet the requirements. Exclusion Criteria: * Pregnancy or lactating with the intent of breast feeding. * Patients who require general anesthesia for MIBG imaging studies.
References
Publications (0)
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