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

NCT ID: NCT01583842

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-09
• Study Completion Date: 2021-02-25

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.

Conditions

Neuroblastoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)

Intervention Type: DRUG

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.

Positron Emission Tomography (PET) /Computerized tomography (CT)

Intervention Type: PROCEDURE

A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.

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.

Group Type: EXPERIMENTAL

124I-MIBG (carrier added)

Intervention Type: DRUG

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.

Positron Emission Tomography (PET) /Computerized tomography (CT)

Intervention Type: PROCEDURE

A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.

Imaging Only

Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG

Group Type: ACTIVE_COMPARATOR

Positron Emission Tomography (PET) /Computerized tomography (CT)

Intervention Type: PROCEDURE

A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.

Interventions

124I-Metaiodobenzylguanidine (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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Positron Emission Tomography (PET) /Computerized tomography (CT)

A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.

Intervention Type: PROCEDURE

Other Intervention Names

124I MIBG; MIBG; 124I MIBG; MIBG; PET/CT

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molecular Insight Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Jubilant DraxImage Inc.

INDUSTRY

Sponsor Role: collaborator

Miguel Pampaloni

OTHER

Sponsor Role: lead

Responsible Party

Miguel Pampaloni

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katherine Matthay, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jose Miguel Hernandez-Pampaloni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Youngho Seo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2012-00617

Identifier Type: REGISTRY

Identifier Source: secondary_id

12088

Identifier Type: -

Identifier Source: org_study_id