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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

October 15, 2020

Study Completion Date

October 15, 2020

Conditions
Metastatic Neuroblastoma
Interventions
DRUG

[124I]meta-Iodobenzylguanidine

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.

Trial Locations (2)

NW1 2PG

University College London Hospital, London

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cancer Research UK

OTHER