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

NCT04438304 | Completed Phase 2

• 1 other identifier: CLS07
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.

  At 4 hours and 20 hours post administration of 64Cu-SARTATE

• Incidence of adverse events related to 64Cu-SARTATE

  1 week post administration of 64Cu-SARTATE

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

64Cu-SARTATE DRUG

64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.

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 at enrolment ≥ 18 years;
• Life expectancy ≥ 12 weeks;
• 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;
• Adequate recovery from acute toxic effects of any prior therapy;
• Adequate renal function (eGFR \>30 ml/min);
• Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;

You may not qualify if:

• Female participant who are pregnant or lactating;
• 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;
• 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;
• Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
• 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).
• 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);
• Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan;
• Participants with extensive marrow/skeletal involvement (\>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (4)

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

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: phase 2
• 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 18, 2020
• Study Start: March 2, 2021
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

AU (4)