68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

NCT ID: NCT02162446

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

Brief 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).

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-OPS202

Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses

Group Type: EXPERIMENTAL

satoreotide trizoxetan

Intervention Type: DRUG

Interventions

satoreotide trizoxetan

Intervention Type: DRUG

Other Intervention Names

68Ga-OPS202

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2014-001881-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OPS-B-001

Identifier Type: -

Identifier Source: org_study_id