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

NCT04440956 | Completed Early Phase 1

• 1 other identifier: CL01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Demonstration of known malignancy

  30 minutes, 1 hour, 4 hours and 24 hours following administration

• Uptake in non-physiological, non-tumor containing tissues

  30 minutes, 1 hour, 4 hours and 24 hours following administration

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: 64Cu-SARTATE

Interventions

64Cu-SARTATE DRUG

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

Also known as: 64Cu-MeCOSar-Octreotate

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

64Cu-SARTATE

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 22, 2020
• Study Start: May 21, 2015
• Primary Completion: February 25, 2016
• Study Completion: February 25, 2016
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share