Clinical Trial · NCT04440956

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

Overview

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.

Sponsor

Clarity Pharmaceuticals

Phase

Early Phase 1

ClinicalTrials.gov

NCT04440956

Drug / Compound

SARTATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: MeCOSar

Eligibility

Inclusion

Low and Intermediate Grade (Ki-67 index \<20%) neuroendocrine tumors (NET)
Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
Life expectancy greater than or equal to 8 weeks
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).

Exclusion

Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
Pregnant or breastfeeding females
Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT \& 64Cu-SARTATE PET/CT scan
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
Known sensitivity or allergy to somatostatin analogues
Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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