TheranosticTrials.org

Clinical Trial · NCT03673943

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

Overview

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

Sponsor

RadioMedix

Phase

Phase 3

Contacts

Ebrahim S Delpassand, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03673943

Drug / Compound

DOTATATE

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

Eligibility

Inclusion

  • CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.
  • 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
  • Confirmed or suspicion of NET based on histology/ biopsy report.

Exclusion

  • Pregnant, planning to be pregnant within the next two weeks
  • Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
  • Inability to provide written consent.