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Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma

NCT01377532 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2020-05-06

No results posted yet for this study

Summary

This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.

Conditions

  • Pheochromocytoma
  • Paraganglioma

Interventions

DRUG

131 I-Metaiodobenzylguanidine (131 I-MIBG)

Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions. A radiation safety officer will instruct the patient, family, and caretakers about specific UCSF radiation safety guidelines for both hospitalization and discharge.

Sponsors & Collaborators

Principal Investigators

  • Paul Fitzgerald, MD · University of California, San Francisco

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01377532 on ClinicalTrials.gov