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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Katherine Matthay, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01583842
First received: April 17, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Neuroblastoma
Radiation: 124I-MIBG (no-carrier added)
Radiation: 124I-MIBG (carrier added)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Number of participants with grade 3 or 4 imaging-related toxicities. [ Time Frame: From baseline up to 6 weeks post final imaging. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
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.


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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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: Patients must have high-risk neuroblastoma with at least ONE of the following:
  • 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.
  • 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.
  • 131I-MIBG Therapy: Patients must meet eligibility criteria for 131I-MIBG therapy.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583842

Contacts
Contact: Katherine Matthay, MD 415-476-3831 matthayk@peds.ucsf.edu

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Sharon Lee    415-514-3658    LeeSS@peds.ucsf.edu   
Contact: Qiu Chen    415-476-0660    ChenQ@peds.ucsf.edu   
Principal Investigator: Katherine Matthay, MD         
Sponsors and Collaborators
Katherine Matthay
Investigators
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
  More Information

No publications provided

Responsible Party: Katherine Matthay, Professor, Department of Pediatrics, and Division Chief, Pediatric Hematology/Oncology, UCSF, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01583842     History of Changes
Other Study ID Numbers: 12088
Study First Received: April 17, 2012
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
neuroblastoma
imaging
124I-MIBG
131I-MIBG
PET/CT

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014