Clinical trial · Interventional
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET
An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)
NCT02162446CI-TRIAL-00040953completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumors | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| satoreotide trizoxetan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-OPS202
- description
- Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses
- interventionNames
- Drug: satoreotide trizoxetan
Primary outcomes (2)
- measure
- 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)
- description
- An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.