Clinical trial NCT02162446: 68Ga-OPS202 Study for Diagnostic Imaging of GEP NET
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
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)
measure: 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)
Secondary outcomes:
measure: Number of Malignant and Benign Lesions Detected for Session 1
timeFrame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
measure: Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
measure: Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1
timeFrame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
measure: Mean SUVmax of Malignant and Benign Lesions for Session 2
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
measure: Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1
timeFrame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
measure: Mean SUVmax of RT for Session 2
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
measure: Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1
timeFrame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
measure: The 3D-SUV-R of Malignant Lesions for Session 2
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
measure: Percent Change in 3D-SUV-R of Malignant Lesions
timeFrame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
measure: Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0
measure: Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0
measure: Best Diagnostic Scan Assessment
timeFrame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: