An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
NCT ID: NCT04440956
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2015-05-21
2016-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intervention
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
64Cu-SARTATE
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
Interventions
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64Cu-SARTATE
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Clarity Pharmaceuticals Ltd
INDUSTRY
Responsible Party
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Other Identifiers
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CL01
Identifier Type: -
Identifier Source: org_study_id
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