TheranosticTrials.org
Clarity Pharmaceuticals

Clinical Trial · NCT04438304

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

Overview

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.

Sponsor

Clarity Pharmaceuticals

Phase

Phase 2

ClinicalTrials.gov

NCT04438304

Drug / Compound

SARTATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: SarAr

Eligibility

Inclusion

  • Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE;
  • 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);

Exclusion

  • Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study;
  • 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.
  • 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);
  • 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;
  • 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;

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

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