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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-SARTATE | Drug | 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000706138 | 64Cu-SARTATE |
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|
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 |
| 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 |
| D009380 | Neoplasms, Nerve Tissue |