drugset / Trial / NCT02043899

A Phase I/II Study of [124I]mIBG PET/CT in Neuroblastoma

NCT02043899 ↗

Phase 1/2 Completed 36 enrolled Cancer Research UK
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2014-02
Primary completion
2020-10-15
Completion
2020-10-15

Outcome

Met primary endpoint

registry analysis (other test); Single Arm Trial; p <0.001; Exact one-sided binomial test NCT02043899 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 124I-Metaiodobenzylguanidine Diagnostic / imaging agent 10 ug Intravenous
Subject 124I-Metaiodobenzylguanidine Diagnostic / imaging agent 1.42 mbq/kg Intravenous
Subject 124I-Metaiodobenzylguanidine Diagnostic / imaging agent 50 mbq Intravenous

Indications