Trial | NCT04440956  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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 Started
May 21
2015
Primary Completion
Feb 25
2016
Study Completion
Feb 25
2016
Last Update
Jun 22
2020

Drug 64Cu-SARTATE

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

  • Other names: 64Cu-MeCOSar-Octreotate

Intervention Experimental

200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.

Criteria 

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
No Results Posted