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

• Status: Completed
• Trial end date: 2019-03-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radiomedix, Inc.
• Treatments: Somatostatin

Criteria

Inclusion Criteria:

• Confirmed or suspicion of NET based on histology/ biopsy report.

• Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET

• CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.

Exclusion Criteria:

• Pregnant, planning to be pregnant within the next two weeks

• Inability to provide written consent.

• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® LAR or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.