An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: 64Cu-SARTATE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>200MBq of 64Cu-MeCOSar-Octreotate (64Cu-SARTATE) given as a single bolus intravenous injection. | Drug: 64Cu-SARTATE<br>* 200MBq of 64Cu-MeCOSar-Octreotate (64Cu-SARTATE) given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.<br>* Other names: 64Cu-MeCOSar-Octreotate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to 64Cu-SARTATE | Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE. | 1 week post administration | 
| Percentage of injected 64Cu-SARTATE dose found in organs of interest | Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan | At 30 minutes following administration | 
| Percentage of injected 64Cu-SARTATE dose found in organs of interest | Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan | At 1 hour following administration | 
| Percentage of injected 64Cu-SARTATE dose found in organs of interest | Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan | At 4 hours following administration | 
| Percentage of injected 64Cu-SARTATE dose found in organs of interest | Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan | At 24 hours following administration | 
| Absorbed organ dose | 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) | At 30 minutes following administration | 
| Absorbed organ dose | 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) | At 1 hour following administration | 
| Absorbed organ dose | 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) | At 4 hours following administration | 
| Absorbed organ dose | 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) | At 24 hours following administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of known malignancy | Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment. | 30 minutes, 1 hour, 4 hours and 24 hours following administration | 
| Uptake in non-physiological, non-tumor containing tissues | Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint. | 30 minutes, 1 hour, 4 hours and 24 hours following administration |