XCancer

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Description:

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)

Government Study Link:

NCT02162446 - Click here to see study on

ClinicalTrials.gov

OPS202

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