Phase I/II study of [124I]mIBG PET/CT in neuroblastoma.
Research type
Research Study
Full title
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.
IRAS ID
114508
Contact name
Sue Chua
Contact email
Sponsor organisation
Cancer Research UK
Eudract number
2012-002029-31
Research summary
Neuroblastoma is the most common tumour of childhood after brain tumours. Approximately half of cases are high risk and despite extensive treatments outcome is very poor. More than 60% of high risk patients suffer relapse or further spread of their disease and long-term survival is below 10%. Existing imaging techniques are not sensitive enough to accurately assess the level of risk which is critical in determining the best choice of treatment. This study will compare a new type of imaging against the existing imaging techniques. The new scans use a new tracer called [124I]mIBG which is taken up by the cancer tissue much more than by normal tissues. This tracer can be used with a 3D imaging technique called PET/CT to pinpoint where the disease has spread and quantify the amount of disease.
A minimum of 25 subjects with neuroblastoma where the original tumour has spread will take part. Subjects will be one year old or older. The majority are expected to be between 3-7 years old. Patients will be those scheduled to have an [123I]mIBG scan for routine care during a planned break in treatment. These scan results will confirm whether the patient has the required 3 or more lesions.
In the next 3-14 days patients will receive one injection of the new tracer and have the study PET/CT scan the following day. Patients can start anti-cancer therapy the next day. Patients will be recruited at two hospitals.
Suitable patients at UCLH will be asked to have a PET/MRI scan straight after the PET/CT scan. Suitable patients at the Royal Marsden will be asked to have four rather than one PET/CT scan, one a day on consecutive days.REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1437
Date of REC Opinion
19 Nov 2013
REC opinion
Further Information Favourable Opinion