CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
[124I]meta-Iodobenzylguanidinedrug
Likely dose
[124I]meta-Iodobenzylguanidine 10 microgramsfrom 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/NCT02043899
NCT02043899Phase 2Completed
CompareCT.gov

A Cancer Research UK Phase I/II Study to Compare [124I]Meta-Iodobenzylguanidine (mIBG) Positron Emission Tomography/Computerised Tomography (PET/CT) to [123I]mIBG Imaging in Patients With Metastatic Neuroblastoma

Cancer Research UK·interventional·Posted Jan 23, 2014·Updated Jun 21, 2021

In Brief

A Phase 2 clinical trial evaluating [124I]meta-Iodobenzylguanidine for Metastatic Neuroblastoma. Completed, enrolled 36 participants across 2 sites.

Detailed Summary

This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called \[124I\]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer) compared to the recommended 1-dimensional routine scans (called \[123I\]mIBG planar scintigraphy).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Neuroblastoma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 23, 2014
Enrollment StartFeb 1, 2014
Primary CompletionOct 15, 2020
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 12.4 years ago

Interventions

[124I]meta-Iodobenzylguanidinedrug

Single intravenous administration of \[124I\]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq \[124I\]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.