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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 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)
Time frame: At 24 hours following administration
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.
Time frame: 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.
Time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration