Back to results124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Primary Purpose
Neuroblastoma
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)
124I-MIBG (carrier added)
Positron Emission Tomography (PET) /Computerized tomography (CT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroblastoma focused on measuring neuroblastoma, imaging, 124I-MIBG, 131I-MIBG, PET/CT
Eligibility Criteria
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
124I-MIBG no-carrier added
124I-MIBG carrier added
Imaging Only
Arm 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.
Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG
Outcomes
Primary Outcome Measures
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
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
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.
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
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
Secondary Outcome Measures
Measurements of tumor dosimetry using low specific activity (carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
Measurements of tumor dosimetry using high specific activity (no carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
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
Full Information
NCT ID
NCT01583842
First Posted
April 17, 2012
Last Updated
May 12, 2021
Sponsor
Miguel Pampaloni
Collaborators
Molecular Insight Pharmaceuticals, Inc., Jubilant DraxImage Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01583842
Brief Title
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Official Title
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding
Study Start Date
April 9, 2013 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miguel Pampaloni
Collaborators
Molecular Insight Pharmaceuticals, Inc., Jubilant DraxImage Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
neuroblastoma, imaging, 124I-MIBG, 131I-MIBG, PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
124I-MIBG no-carrier added
Arm Type
Experimental
Arm 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.
Arm Title
124I-MIBG carrier added
Arm Type
Experimental
Arm 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.
Arm Title
Imaging Only
Arm Type
Active Comparator
Arm Description
Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG
Intervention Type
Drug
Intervention Name(s)
124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)
Other Intervention Name(s)
124I MIBG, MIBG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
124I-MIBG (carrier added)
Other Intervention Name(s)
124I MIBG, MIBG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET) /Computerized tomography (CT)
Other Intervention Name(s)
PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurements of organ dosimetry using high specific activity (no carrier added)
Description
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
Title
Measurements of organ dosimetry using low specific activity (carrier added)
Description
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
Title
Number of participants with grade 3 or 4 imaging-related toxicities.
Description
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
Title
Change from baseline of blood pressure
Description
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
Title
Change from baseline of pulse measurements
Description
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
Secondary Outcome Measure Information:
Title
Measurements of tumor dosimetry using low specific activity (carrier added)
Description
Descriptive statistics will be used to report the tumor dosimetry data
Time Frame
Up to 7 weeks
Title
Measurements of tumor dosimetry using high specific activity (no carrier added)
Description
Descriptive statistics will be used to report the tumor dosimetry data
Time Frame
Up to 7 weeks
Title
Assessment of the accuracy of tumor imaging
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Matthay, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Miguel Hernandez-Pampaloni, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youngho Seo, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
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