An imaging study of 64Cu-SARTATE using positron emission tomography in patients with neuroendocrine tumours
Safety and Potential Effectiveness of Positron Emission Tomography (PET) Imaging of Patients with Low & Intermediate Grade Neuroendocrine Tumors using 64Cu-SARTATE: A Single Centre, Open-Label, Non-Randomized, Phase-0 Microdosing Investigation
Clarity Pharmaceuticals PTY LTD
10 participants
May 21, 2015
Interventional
Conditions
Summary
The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers. Who is it for? You may be eligible to join this study if you are aged 18 years or over, have a life expectancy of 8 weeks or more and Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET). Study details: All participants in this study will be injected with a single dose of 64Cu-SARTATE (a drug molecule). The study lasts for one week and the patient is administered 1 dose of the drug followed by whole body PET scans at 30mins, 1hr, 4hrs, & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & visit 3 (day 8). These scans will be compared to the current PET imaging standard called 68Ga-DOTATATE which you will have recently received as a standard procedure. It is hoped that this research will help to develop a product which is more accurate for the diagnosis of neuroendocrine tumours in patients.
Eligibility
Inclusion Criteria7
- Signed informed consent
- Age greater than or equal to 18 years
- Life expectancy greater than or equal to 8 weeks
- Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
- At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care
- Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
Exclusion Criteria8
- Pregnant or breastfeeding females
- Known sensitivity or allergy to somatostatin analogues
- Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan
- Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
- Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
- QTc interval greater than 0.44seconds as measured by screening ECG
- Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
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Interventions
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection at day 1. SARTATE dose will not exceed 10micrograms. Followup will occur at 1 week.
Locations(1)
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ACTRN12615000727549