68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Ipsen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Treatments

Drug: satoreotide trizoxetan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02162446

OPS-B-001

2014-001881-88 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.