To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Condition: Gastro-Enteropancreatic Neuroendocrine Tumor
MeSH terms: Neuroendocrine Tumors
Intervention: Satoreotide trizoxetan 5-20μg; Satoreotide trizoxetan 30-45μg
Intervention description: Positron emission tomography (PET) imaging agent; Positron emission tomography (PET) imaging agent
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Masking description: All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide
      trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect
      and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a
      radiolabelled imaging agent to be used in association with Positron-Emission-Tomography
      (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic
      somatostatin analogue which binds to the somatostatin receptor (type 2) present on the
      surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can
      be seen in the PET scanner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed, well differentiated functioning or non-functioning
             metastatic GEP-NET (Grade I and II as per World Health Organisation classification
             2010)

          -  Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour
             lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months
             prior to screening (Visit 1) and showing minimally two lesions in at least one of the
             key organs; these images shall be available to be sent to the imaging core lab
             electronically to ascertain quality and admissibility

          -  Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive

          -  Adequate bone marrow, liver and renal function

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

        Exclusion Criteria:

          -  Fewer than five lesions in total and more than 25 lesions/organ detected by the
             previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs

          -  Subject who have received treatment of any somatostatin analogue, including
             Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within
             24 hours prior to first 68Ga-OPS202 administration

          -  Prior or planned administration of a radiopharmaceutical within 8 half-lives of the
             radionuclide

          -  Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects
             who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or
             arthroplasty, or any other objects that might interfere with the PET and/or CT
             analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects
             unable to lie still for the entire imaging time, e) Subjects weighing greater than 110
             kg (243 lb)