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Radioactive Agent

Ultratrace® Iobenguane I 131 Treatment for Paraganglioma

Phase 2
Waitlist Available
Led By Jeffrey Olsen, MD
Research Sponsored by Molecular Insight Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years (60 months)
Awards & highlights

Study Summary

This clinical trial is designed to evaluate the effectiveness and collect additional safety information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or relapsed/refractory (to other treatment) or unresectable pheochromocytoma or paraganglioma. The purpose of this trial is to test the use of AZEDRA® as a treatment for pheochromocytoma and paraganglioma, a rare disease. This Phase II study will help determine primarily if using the drug reduces the amount of blood pressure medication being taken as a result of the cancer and secondarily to determine such things as the effectiveness of the study drug in treating the cancer, additional safety measures, and to assess if the drug helps the quality of life and use of pain medication. All subjects will receive an imaging dose with scans followed by two therapeutic doses given approximately 3 months apart.

Eligible Conditions
  • Paraganglioma
  • Pheochromocytoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years (60 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years (60 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients Who Experienced a 50% or Greater Reduction (Including Discontinuation) of All Antihypertensive Medication(s) Lasting for at Least Six Months.
Secondary outcome measures
Best Confirmed Overall Tumor Response of Complete Response (CR) or Partial Response (PR) by RECIST 1.0.
Changes From Baseline in Overall Quality of Life (QoL) - Best Response Within 12 Months After First Therapeutic Dose of AZEDRA®.
Overall Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ultratrace® Iobenguane I 131 TreatmentExperimental Treatment1 Intervention

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Who is running the clinical trial?

Molecular Insight Pharmaceuticals, Inc.Lead Sponsor
20 Previous Clinical Trials
1,330 Total Patients Enrolled
4 Trials studying Paraganglioma
72 Patients Enrolled for Paraganglioma
Jeffrey Olsen, MDPrincipal InvestigatorMallinckrodt Institute of Radiology Washington University
Joseph Dillon, MDPrincipal InvestigatorUniversity of Iowa

Frequently Asked Questions

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~5 spots leftby Apr 2025