2
Participants
Start Date
June 30, 2014
Primary Completion Date
June 30, 2016
Study Completion Date
June 30, 2016
[I-124]-CPD-1028 Injection
A single intravenous dose of \[I-124\]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed.
CPD-1061
\[Optional\] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of \[I-124\]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data.
St. Joseph's Healthcare Hamilton, Hamilton
Juravinski Cancer Centre, Hamilton
Sunnybrook Health Science Centre - Odette Cancer Centre, Toronto
University Health Network - Princess Margaret Cancer Centre, Toronto
Centre for Probe Development and Commercialization
OTHER