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

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.

Conditions

• Neuroblastoma

Interventions

DRUG

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.

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.

PROCEDURE

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.

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Jubilant DraxImage Inc.

  collaborator INDUSTRY

• Miguel Pampaloni

  lead OTHER

Principal Investigators

• Katherine Matthay, MD · University of California, San Francisco

• Jose Miguel Hernandez-Pampaloni, MD, PhD · University of California, San Francisco

• Youngho Seo, PhD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-09

Primary Completion

2021-02-25

Completion

2021-02-25

FDA Drug

Yes

Countries

• United States

Study Locations