None listed
Conditions
Brief summary
The aim of this project is to investigate if a novel tracer called 64Cu-SARTATE can be used to help accurately image neuroblastoma on PET/CT in pediatric patients. Who is it for? Paediatric patients aged 16 years or less diagnosed with high-risk neuroblastoma and life expectancy of 12 weeks or more are eligible for this study. Study details Eligible patients will be administered a single dose of 64Cu-SARTATE and undergo whole body PET scans at 4hrs & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & the visit 3 (day 8). Three blinded assessors will compare the new scans to the standard of care imaging to determine if they are superior. We hope that by testing this investigational product in paediatric patients, we can confirm that the biodistribution of 64Cu-SARTATE will facilitate specific and more sensitive identification of malignant tissues using PET/CT scanning. It is hoped that this method can then be translated into everyday clinical care.
Interventions
64Cu-SARTATE will be administered at a rate of 2.0MBq/kg (0.054 mCi/kg) of body weight, up to a maximum of 200 MBq (5.4 mCi) given as a single bolus IV injection at day 1. Follow-up will occur at 1 week.
Sponsors
Clarity Pharmaceuticals LTD
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 22 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent by parent or guardian. 2. Age at diagnosis less than or equal to 16 years. 3. Life expectancy greater than or equal to 12 weeks. 4. High-risk neuroblastoma with failure to respond to standard therapy, or development of progressive disease at any time, or patients with unresectable residual primary tumours if unsuitable for external beam radiotherapy. 5. At least one site of disease evaluable by 123I-MIBG SPECT. 6. Adequate recovery from acute toxic effects of any prior therapy. 7. At least one site of somatostatin receptor 2 positive malignancy. 8. Adequate renal function. 9. Karnofsky or Lansky performance status of greater than or equal to 50.
Exclusion criteria
1. Patients with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the principal investigator or treating sub-investigator. 2. Patients who require sedation during imaging procedures. 3. Patients must not receive chemotherapy, anti-cancer cytokine therapy or other investigational agents within 2 weeks prior to Day 1. 4. Patients must not be undergoing treatment with long acting somatostatin analogues (administered within 28 days prior to Day 1), or short acting somatostatin analogues (administered within 24hrs prior to Day 1). 5. Patients who are pregnant or lactating are excluded. Patients of childbearing potential must practice an effective method of birth control. 6. Patients who are on hemodialysis. 7. Patients with a QTc interval less than or equal to 0.45 seconds as measured by screening ECG. 8. Patients with uncontrolled infections. 9. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study.
Outcome results
None listed