A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)

Positron Emission Tomography Imaging of Participants With Known or Suspected Neuroendocrine Tumours Using 64Cu SARTATE: A Multi-Centre, Single Arm, Non-Randomised, Blinded-Review, Phase II Study

The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors (NETs) as a potential new way to help diagnose NETs.

Study Overview

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

Detailed Description

Up to 63 participants will be recruited in this study and who are confirmed or suspected to have NETs based on biochemical evidence or that of conventional anatomical or molecular imaging.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clarity Pharmaceuticals; Phone Number: +61 (0) 2 9209 4037; Email: clinicaltrials@claritypharmaceuticals.com

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2751
      • Recruiting
      • Nepean Hospital
      • Principal Investigator: Veronica Wong, MD
    • Sydney, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
      • Principal Investigator: David Chan, MD
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
      • Principal Investigator: Nimit Singhal, MD
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
      • Principal Investigator: Grace Kong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent;
2. Age at enrolment ≥ 18 years;
3. Life expectancy ≥ 12 weeks;
4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET;
5. Adequate recovery from acute toxic effects of any prior therapy;
6. Adequate renal function (eGFR >30 ml/min);
7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;

Exclusion Criteria:

1. Female participant who are pregnant or lactating;
2. Male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. Abstinence is considered acceptable;
3. Participant has received any treatment (including experimental treatment) for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan;
4. Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
5. History of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study).
6. Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment);
7. Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan;
8. Participants with extensive marrow/skeletal involvement (>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection.	Drug: 64Cu-SARTATE; 64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.; Other Names: 64Cu-MeCOSar-Octreotate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 hours post administration of 64Cu-SARTATE
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 20 hours post administration of 64Cu-SARTATE
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings	Lesion detection rate on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 and 20 hours post administration of 64Cu-SARTATE
To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE	Concordance measured on a per-lesion basis	At 4 hours post administration of 64Cu-SARTATE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.	Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.; Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.	At 4 hours and 20 hours post administration of 64Cu-SARTATE
Incidence of adverse events related to 64Cu-SARTATE	Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	1 week post administration of 64Cu-SARTATE

Collaborators and Investigators

• Sponsor: Clarity Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

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: CLS07

Drug and device information, study documents

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