An Early Phase 1 interventional study of 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) and 124I-MIBG (carrier added) in Neuroblastoma, sponsored by Miguel Pampaloni. Terminated at 1 site in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Miguel Pampaloni · Early Phase 1, Interventional, and Diagnostic
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.
Accurate radiation dose evaluation is important in patients with malignant tumors, and this is especially critical in children with NB who will be receiving several dose of therapeutic 131I. The accurate quantification of the isotope-labeled analog can only be achieved by using positron emission compounds, such as 124I. Unlike planar images, which were used to obtain kinetic information, and SPECT reconstruction modalities that were aimed to assess the spatial distribution of radioactivity, 3D PET imaging-based dosimetry is a method which provides a more accurate estimation of the cumulated radioactivity distribution. Because PET provides better quantitative accuracy, when compared to SPECT regarding the tissue absorbed information, we hypothesize PET would better correspond with tumor response and normal organ toxicity. Early studies using I-124 for dosimetry in thyroid cancer have been promising.
Demonstration of the feasibility and accuracy of this new imaging modality, with the excellent prospect for more accurate dosimetry, will improve tumor localization and optimize therapeutic dosing with 131I-MIBG. The results of our work may potentially have also implications in the study of other neuroendocrine tumors. The Section of Nuclear Medicine and the Laboratory of Functional Imaging at the University of California, San Francisco, are equipped with state of the art instruments and is run by a highly skilled staff which will guarantee the success of the proposed research.
Imaging only cohort:
Exclusion Criteria:
Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
Drug: 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added) · Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)
Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
Drug: 124I-MIBG (carrier added) · Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)
Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG
Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)
124I-MIBG (no-carrier added) Administration (infusion, 1-2 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Optional 124I-MIBG (no-carrier added) Administration \& PET/CT scan 6 weeks later.
Also known as: 124I MIBG, MIBG
124I-MIBG (carrier added) Administration (infusion, 60 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Optional 124I-MIBG (carrier added) Administration \& PET/CT scan 6 weeks later.
Also known as: 124I MIBG, MIBG
A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.
Also known as: PET/CT
Measurements of organ dosimetry using high specific activity (no carrier added)
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
Time frame: Up to 7 weeks
Measurements of organ dosimetry using low specific activity (carrier added)
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
Time frame: Up to 7 weeks
Number of participants with grade 3 or 4 imaging-related toxicities.
All patients will have toxicity monitoring for 6 weeks following 124I-MIBG administration. Toxicities will be graded according to the NCI Common Toxicity Criteria for Adverse Events (CTCAEv4.0)and attribution assigned.
Time frame: Up to 7 weeks
Change from baseline of blood pressure
Blood pressure will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
Time frame: Up to 7 weeks
Change from baseline of pulse measurements
Participants pulse will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
Time frame: Up to 7 weeks
Measurements of tumor dosimetry using low specific activity (carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
Time frame: Up to 7 weeks
Measurements of tumor dosimetry using high specific activity (no carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
Time frame: Up to 7 weeks
Assessment of the accuracy of tumor imaging
Descriptive statistics will be used to report the tumor dosimetry data compared to using 123I-MIBG scan with 3-dimensional imaging by SPECT or SPECT/CT
Time frame: Up to 7 weeks
Plan to share: No
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Miguel Pampaloni