68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

Inclusion Criteria:

• A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.

• 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.

• 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)

• ECG: any abnormalities have to be clarified by a cardiologist.

• Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.

• Calculated GFR ≥ 45 mL/min.

• Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

• 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.

• Presence of active infection at screening or history of serious infection within the previous 6 weeks.

• 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.

• Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below).

• Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug.

• Administration of another investigational medicinal product within 30 days prior to entry.

• Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.

• Current > grade 2 toxicity from previous standard or investigational therapies, per US-NCI "Common Terminology Criteria for Adverse Events v4.0".

• Pregnant or breast-feeding women.

• History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

• Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.

• Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included.