Status:
COMPLETED
An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
Lead Sponsor:
Clarity Pharmaceuticals Ltd
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04440956
Start Date
May 21 2015
End Date
February 25 2016
Last Update
June 22 2020
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