Clinical trial NCT01583842: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Neuroblastoma
Keywords: neuroblastoma
imaging
124I-MIBG
131I-MIBG
PET/CT
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Molecular Insight Pharmaceuticals, Inc.
name: Jubilant DraxImage Inc.
First posted: 2012-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Measurements of organ dosimetry using high specific activity (no carrier added)
timeFrame: Up to 7 weeks
measure: Measurements of organ dosimetry using low specific activity (carrier added)
timeFrame: Up to 7 weeks
measure: Number of participants with grade 3 or 4 imaging-related toxicities.
timeFrame: Up to 7 weeks
measure: Change from baseline of blood pressure
timeFrame: Up to 7 weeks
measure: Change from baseline of pulse measurements
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Measurements of tumor dosimetry using low specific activity (carrier added)
timeFrame: Up to 7 weeks
measure: Measurements of tumor dosimetry using high specific activity (no carrier added)
timeFrame: Up to 7 weeks
measure: Assessment of the accuracy of tumor imaging
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katherine Matthay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jose Miguel Hernandez-Pampaloni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Youngho Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References: