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

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 Overview

• Status: Completed
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: 64Cu-SARTATE

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Clarity Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2015
• Primary Completion (ACTUAL): February 25, 2016
• Study Completion (ACTUAL): February 25, 2016

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: CL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No