gastroenteropancreatic neuroendocrine tumour (GEP-NET) GEP-NET
Conditions
Interventions
i.v. injections of two different peptide/radioactivity dose of 68Ga-OPS202
followed by PET/CT scan imaging 1 hour post dosing (up to 80 min)
- 68Ga-OPS202
- dose confirmation
- Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
- PET imaging agent
Sponsors
Ipsen Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Men or women aged 18 years or older;(2) Subjects with pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per WHO classification 2010);(3) Subjects with a 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 namely liver, lymph nodes, bone or lungs; these images shall be available to be sent to the ICL electronically to ascertain quality and admissibility;(4) Eastern Cooperative Oncology Group (ECOG) performance status * 2;(5) Subjects with body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive;(6) Adequate bone marrow, liver and renal function, with:;* Calculated Glomerular filtration rate (GFR) * 45 mL/min * Albumin: > 30 g/L * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): * 5 times upper limit of normal (ULN) * Bilirubin: * 3 times ULN (3 × 1.1 mg/dL) * Leukocytes: * 3*109/L and neutrophils * 1*109/L * Erythrocytes: * 3.5*1012/L * Platelets: * 90*109/L;(7) Signed written informed consent prior to any study-related procedures
Exclusion criteria
Exclusion criteria: (1) Subjects with fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor positive scan in key organs: liver, lymph nodes, bone or lung;(2) 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.;(3) Presence of active infection at screening or history of serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration;(4) Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide;(5) Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration;(6) Known hypersensitivity to NODAGA, to Gallium-68, to JR11 or to any of the excipients of 68Ga-OPS202;(7) History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids;(8) Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C;(9) 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);(10) Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration;(11) Female subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to each 68Ga-OPS202 administration;(12) Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude;(13) Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or subjects treated with curative intent and free from disease for more than 5 years) other than NET
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint and Evaluation: *For each combination of injected peptide/radioactivity dose ranges, differences in relative lesion counts derived from a 2 × 3 factorial analysis measuring the ratio of the number of lesions detected by 68Ga-OPS202 to the number of lesions assessed by standard-of-truth (descriptive analyses). The standard-of-truth in the present study is the CT scan images acquired at Visit 2 and Visit 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints and evaluations: Key secondary endpoint: *For each combination of injected peptide/radioactivity dose ranges, differences in image quality derived from a 2 × 3 factorial analysis measuring the tumour-to-background ratio in each of the major anatomic sites (i.e. descriptive analyses for liver, lymph nodes, bone and lung) A qualitative analysis of the image assessed by the independent blinded readers will be performed to back up the quantitative quality measured by tumour-to-background analysis. | — |
Countries
The Netherlands
Outcome results
None listed