TheranosticTrials.org

Clinical Trial · NCT01879657

68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)

Overview

To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Ebrahim Delpassand, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01879657

Drug / Compound

DOTATATE

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

penteoctreotide

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

Eligibility

Inclusion

  • Serum creatinine: Serum creatinine: \<170 μmol/L
  • egative pregnancy test in women capable of child-bearing
  • Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN \[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\], Bilirubin: ≤3 times ULN \[ULN for total bilirubin is 1.3mg/dL\]
  • Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day

Exclusion

  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug
  • Pregnant or breast-feeding women
  • Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE