A Diagnostic Imaging Study of 64Cu-SARTATE™ for Neuroendocrine Tumours

UPDATE 4th July 2026. From a presentation at SNMII 2026 “New prospective comparative research suggests that the PET/CT radiopharmaceutical ⁶⁴Cu-SARTATE may offer significant advantages over ⁶⁸Ga-DOTATATE for detecting liver foci in patients with known or suspected neuroendocrine tumors (NETs)” click here

UPDATE 23rd December 2025. (Originally published Apr 2021). Phase 3 trial in discussion (clinical trials reference detail to follow)

Sydney, Australia 22 December 2025

Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce it will be commencing a pivotal Phase III registrational trial of its ⁶⁴Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours (NETs). This follows a successful End of Phase meeting with the United States (US) Food and Drug Administration (FDA), in which all key components of the proposed trial design were agreed upon with the Agency. Recruitment into the trial is expected to commence in 2026.

The trial will be a multi-centre, single arm, non-randomised, open-label Phase III diagnostic clinical trial of ⁶⁴Cu-SARTATE Positron Emission Tomography (PET) in approximately 70 participants. As a pivotal trial, the final study results are intended to support an application to the US FDA for approval of ⁶⁴Cu-SARTATE as a new diagnostic imaging agent in NETs.

Original blog:

A Diagnostic Imaging Study of ⁶⁴Cu-SARTATE™ Using Positron Emission Tomography (PET) on Patients With Known or Suspected NETs

Reference: NCT04438304

Trial status: Recruiting

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

63 patient multicentre study run in Australia.

Clinical sites:

Royal North Shore Hospital
Peter MacCallum Cancer Centre
Royal Adelaide Hospital

How does it compare to Ga68 Dotatate?

Site: Peter MacCallum Cancer Centre,
Principal Investigator: Prof Rod Hicks

In comparison to ⁶⁸Ga-DOTATATE scans, ⁶⁴Cu-SARTATE^TM imaging in participants with NETs was equivalent at 1 hour, and superior at 4 hours, allowing detection of additional tumours at later time points.

Resource links

1. SSTR PET – all you need to know – read more here.

2. If you can see it, you can detect it. Click here.

3. How to understand your SSTR PET report. Click here.

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Finally

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