TheranosticTrials.org

Clinical Trial · NCT02162446

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Overview

The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).

Sponsor

Ipsen

Phase

Phase 1/2

Contacts

Ipsen Medical Director (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02162446

Drug / Compound

OPS202

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

Eligibility

Inclusion

  • * A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
  • Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
  • Blood test results as follows (WBC: ≥ 3\*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
  • A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
  • At least 1 lesion detected by the previous somatostatin receptor scan.

Exclusion

  • * Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202.
  • History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids.
  • Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
  • Any condition that precludes raised arms position for prolonged imaging purposes.
  • Presence of active infection at screening or history of serious infection within the previous 6 weeks.