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Withdrawn Phase 2 Interventional

Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma

ClinicalTrials.gov ID: NCT00992173

Public ClinicalTrials.gov record NCT00992173. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 10:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die. In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.

Study identification

NCT ID
NCT00992173
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 2
Enrollment
Not listed

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Months and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2009
Primary completion
Sep 30, 2011
Completion
Not listed
Last update posted
Nov 25, 2015

Started 2010

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
16
Facility City State ZIP Site status
Children's Hospital of LA Los Angeles California 90027
UCSF Pediatric Hematology/Oncology San Francisco California 94143
University of Miami Miller School of Medicine Miami Florida 33136
Childrens Memorial/Northwestern University Chicago Illinois 60614
Comer's Childrens Hospital/University of Chicago Chicago Illinois 60637
University of iowa Iowa City Iowa 52242
Johns Hopkins University Baltimore Maryland 21287
Children's Hospital/Dana Farber Cancer Institute Boston Massachusetts 02115
CS Motts Children's Hospital Ann Arbor Michigan 48105
Mount Sinai School of Medicine New York New York 10029
Hospital - Weill Cornell Medical Center New York New York 10032
Memorial Sloan Kettering New York New York 10065
Duke University Medical Center Durham North Carolina 27710
Cincinnati Children's Hospital Cincinnati Ohio 45229
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Medical University of South Carolina Charleston South Carolina 29425
Cook Children's Healthcare System Fort Worth Texas 76104
MD Anderson Cancer Center Houston Texas 77030
Texas Childrens Hospital Cancer Center Houston Texas 77030
University of Wisconsin Medical Center Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00992173, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 25, 2015 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00992173 live on ClinicalTrials.gov.

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