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
Overview
- Phase
- Early Phase 1
- Intervention
- 64Cu-SARTATE
- Conditions
- Neuroendocrine Tumors
- Sponsor
- Clarity Pharmaceuticals Ltd
- Enrollment
- 10
- Primary Endpoint
- Incidence of adverse events related to 64Cu-SARTATE
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Intervention
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
Intervention: 64Cu-SARTATE
Outcomes
Primary Outcomes
Incidence of adverse events related to 64Cu-SARTATE
Time Frame: 1 week post administration
Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
Absorbed organ dose
Time Frame: At 24 hours following administration
Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
Percentage of injected 64Cu-SARTATE dose found in organs of interest
Time Frame: At 24 hours following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
Secondary Outcomes
- Uptake in non-physiological, non-tumor containing tissues(30 minutes, 1 hour, 4 hours and 24 hours following administration)
- Demonstration of known malignancy(30 minutes, 1 hour, 4 hours and 24 hours following administration)