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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04440956
Other study ID # CL01
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 21, 2015
Est. completion date February 25, 2016

Study information

Verified date June 2020
Source Clarity Pharmaceuticals Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 25, 2016
Est. primary completion date February 25, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Signed informed consent

2. Age greater than or equal to 18 years

3. Life expectancy greater than or equal to 8 weeks

4. Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)

5. 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

6. Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).

7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

Exclusion Criteria:

1. Pregnant or breastfeeding females

2. Known sensitivity or allergy to somatostatin analogues

3. Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan

4. Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product

5. Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product

6. QTc interval greater than 0.44seconds as measured by screening ECG

7. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study

8. Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
64Cu-SARTATE
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Clarity Pharmaceuticals Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
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