Clinical Trial: 68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive G

Brief Summary: 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).

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome:

  • Safety and tolerability of 68Ga-OPS202 (laboratory parameters) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Laboratory assessments will include hematology, blood biochemistry and urine analysis
  • Safety and tolerability of 68Ga-OPS202 (vital signs) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Vital signs will include systolic and diastolic blood pressure, heart rate and axillary body temperature
  • Safety and tolerability of 68Ga-OPS202 (ECGs) [ Time Frame: 4 weeks before to 5 weeks after first dose of 68Ga-OPS202 ]
    Cardiac safety will be assessed by 12-lead ECGs
  • Safety and tolerability of 68Ga-OPS202 as assessed by determination of number of patients with adverse events [ Time Frame: until 5 weeks after first dose of 68Ga-OPS202 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Determination of AUC0-last of 68Ga-OPS202 in discernible thoracic and abdominal organs, target lesion and blood [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  • Determination of Cmax (maximum concentration achieved in units of Bq/ml) for target lesion [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  • Determination of Cmax (maximum concentration achieved in units of Bq/ml) for discernible organs and blood [ Time Frame: 0 (pre-dose) to 4h post-dose ]
  • Determination of Tmax for target lesion [ Time Frame: 0 (pre-dose) to 4h post-dose ]
    Determination of the time post-injection to achieve maximum tumor concentration
  • Determination of Tmax for blood and organs [ Time Frame: 0 (pre-dose) to 4h post-dose ]
    Determination of the time post-injection to achieve maximum organ and blood concentration


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: June 3, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 17, 2016
Last Verified: March 2016