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124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
2 other identifiers
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Apr 2013
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedStudy Start
First participant enrolled
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2021
CompletedMay 14, 2021
May 1, 2021
7.9 years
April 17, 2012
May 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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.
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
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
Up to 7 weeks
Secondary Outcomes (3)
Measurements of tumor dosimetry using low specific activity (carrier added)
Up to 7 weeks
Measurements of tumor dosimetry using high specific activity (no carrier added)
Up to 7 weeks
Assessment of the accuracy of tumor imaging
Up to 7 weeks
Study Arms (3)
124I-MIBG no-carrier added
EXPERIMENTALPatients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
124I-MIBG carrier added
EXPERIMENTALPatients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
Imaging Only
ACTIVE COMPARATORParticipants with high-risk neuroblastoma will receive imaging only without 124I-MIBG
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- I-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.
You may not qualify if:
- Pregnancy or lactating with the intent of breast feeding.
- Patients who require general anesthesia for MIBG imaging studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miguel Pampalonilead
- Molecular Insight Pharmaceuticals, Inc.collaborator
- Jubilant DraxImage Inc.collaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Matthay, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Jose Miguel Hernandez-Pampaloni, MD, PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Youngho Seo, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 24, 2012
Study Start
April 9, 2013
Primary Completion
February 25, 2021
Study Completion
February 25, 2021
Last Updated
May 14, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share