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

Phase 2
Waitlist Available
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 hours post administration of 64cu-sartate
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Neuroendocrine Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 and 20 hours post administration of 64cu-sartate
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 and 20 hours post administration of 64cu-sartate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE
Secondary study objectives
Incidence of adverse events related to 64Cu-SARTATE
To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SARTATE
2015
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
679 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors
~13 spots leftby Dec 2025
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