Clinical Trial Finder

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

Study 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 3 Years and Over
Gender All
More Inclusion & Exclusion 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 - 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01583842

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Katherine Matthay

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Neuroblastoma
Additional Details

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.

Contact a Trial Team

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University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Elizabeth Pon

elizabeth.pon@ucsf.edu

415-476-2218

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