NCT03673943

Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE

An Open-label, Single-dose, Single Arm, Single-center Clinical Trial of 64Cu(Copper)-DOTATATE (NETMedix™) PET-CT Scan for Imaging Patients With Known or Suspected Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Radiomedix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.

Detailed description

In total, 59 subjects will be recruited in the study. The study will recruit both healthy volunteers as well as patients with confirmed or suspicious NET disease by histology or conventional anatomical and functional imaging modalities including but not limited to magnetic resonance imaging (MRI), and/or computed tomography (CT), and/or, F-18 FDG fluorodeoxyglucose PET (positron emission tomography)/CT and /or F-18 NaF sodium fluoride bone PET/CT and/or bone scintigraphy, and/or Octreoscan.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	64Cu-DOTATATE	Detection of somatostatin positive lesions in NET

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-03-23
• Completion: 2019-08-07
• First posted: 2018-09-17
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study