68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Ipsen12 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Interventions

satoreotide trizoxetanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

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.

Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication

Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.

Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)

Secondary Outcomes

Number of Malignant and Benign Lesions Detected for Session 1

At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.

Data from ClinicalTrials.gov

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