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Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

NCT00730444 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2009-11-09

No results posted yet for this study

Summary

GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection (\[123I\]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for \[123I\]mIBG imaging.

Conditions

Interventions

DRUG

Iobenguane I 123 Injection

1-10 mCi administered intravenously

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Arnold Jacobson, MD · GE Healthcare

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730444 on ClinicalTrials.gov