CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
131I-MIBGradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01413503
NCT01413503Phase 2Completed
CompareCT.gov

A Phase II Study of 131I-labeled Metaiodobenzylguanidine (MIBG) for Treatment of Patients With Metastatic or Unresectable Pheochromocytoma and Related Tumors

University of California, San Francisco·interventional·Posted Aug 10, 2011·Updated Sep 18, 2018

In Brief

A Phase 2 clinical trial evaluating 131I-MIBG for Pheochromocytoma and Paraganglioma. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This is an ongoing prospective Phase II clinical trial evaluating the efficacy of 131I-MIBG for the treatment of patients with metastatic or unresectable pheochromocytoma and related tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPheochromocytoma, Paraganglioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2011
Enrollment StartMay 1, 1991
Primary CompletionSep 6, 2007
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 16.3 yearsPosted 14.9 years ago

Interventions

131I-MIBGradiation

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 1200 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.