68Ga-OPS202 Study for Diagnostic Imaging of GEP NET (NCT02162446) | Clinical Trial Compass
CompletedPhase 1/2
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET
Switzerland12 participantsStarted 2014-06
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)
2
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication
Timeframe: From start of IP administration to end of the study visit (approximately 28 to 36 days)