Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01583842
Recruitment Status : Suspended (Funding)
First Posted : April 24, 2012
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Katherine Matthay, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 17, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date April 2, 2020
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
  • Measurements of organ dosimetry using high specific activity (no carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma [ Time Frame: Participants will have PET/CT scans on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
  • Measurements of organ dosimetry using low specific activity (carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma [ Time Frame: Participants will have PET/CT scans on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
  • Change from baseline of blood pressure measurements at week 7. [ Time Frame: Participants will have safety assessments on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
  • Number of participants with grade 3 or 4 imaging-related toxicities. [ Time Frame: From baseline up to 6 weeks post final imaging. ]
  • Change from baseline of pulse measurements at 7 weeks. [ Time Frame: Participants will have safety assessments on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
  • Measurements of tumor dosimetry using low specific activity (carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma. [ Time Frame: Participants will have PET/CT scans on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
  • Assessment of the accuracy of tumor imaging using 124I-MIBG PET/CT versus 123I-MIBG scan with 3-dimensional imaging by SPECT or SPECT/CT by number, intensity of uptake and localization of sites of tumor. [ Time Frame: Participants will have 124I-MIBG administration and PET/CT scans on Days 0, 1, 2, and Day 5. An optional 124I-MIBG administration and scan will occur about 6 weeks later. Average study participation is approximately 7 weeks. ]
  • Measurements of tumor dosimetry using high specific activity (no carrier added) 124I-MIBG PET/CT in patients with refractory or relapsed neuroblastoma. [ Time Frame: Participants will have PET/CT scans on Days 0 - week 7. Average study participation is approximately 7 weeks. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
Official Title  ICMJE 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroblastoma
Intervention  ICMJE
  • Radiation: 124I-MIBG (no-carrier added)

    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.

  • Radiation: 124I-MIBG (carrier added)

    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.

Study Arms  ICMJE
  • Experimental: 124I-MIBG no-carrier added
    Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
    Intervention: Radiation: 124I-MIBG (no-carrier added)
  • Experimental: 124I-MIBG carrier added
    Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG.
    Intervention: Radiation: 124I-MIBG (carrier added)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: Patients must be >/= 3 years of age and able to cooperate for the PET CT scan when registered on study.
  • Diagnosis: 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.
  • Disease Status - To be eligible for the MIBG pre-therapy dosimetry:
  • Recurrent/progressive disease at any time. Biopsy is not required, even if there is a partial response to intervening therapy.
  • 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.
  • Imaging only cohort
  • For patients participating in the imaging cohort only, 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.
  • 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.
  • Reproductive Function: All post-menarchal females must have a negative beta-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.

Exclusion Criteria:

  • Pregnancy or lactating with the intent of breast feeding.
  • Patients who require general anesthesia for MIBG imaging studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583842
Other Study ID Numbers  ICMJE 12088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katherine Matthay, University of California, San Francisco
Study Sponsor  ICMJE Katherine Matthay
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of California, San Francisco
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP