124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
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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 |
- 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 ]
- 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 |
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| Contact: Katherine Matthay, MD | 415-476-3831 | matthayk@peds.ucsf.edu |
| 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 | |
| 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 June 17, 2013