Clinical trial NCT03220217: To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Official title: A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastro-Enteropancreatic Neuroendocrine Tumor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
* Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
* Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
* Adequate bone marrow, liver and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

* Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
* Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
* Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
* Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)

Primary outcomes:
measure: Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
measure: Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
Secondary outcomes:
measure: Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
timeFrame: Day 1 and Days 16 to 22
measure: Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
measure: Image Quality as Assessed by Independent Blinded Readers Quality Score
timeFrame: Day 1 and Days 16 to 22
measure: Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
measure: Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
measure: Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
timeFrame: Day 1 and Days 16 to 22
measure: Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
measure: Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
timeFrame: Day 1 and Days 16 to 22
measure: Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
timeFrame: Day 1 and Days 16 to 22
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Vienna
country: Austria
facility: University Clinic for Radiology and Nuclear Medicine
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University of Copenhagen
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Miller CG, Gronbaek H, Virgolini I, Kjaer A, Terve P, Bahri S, Iversen P, Svirydenka H, Rohban T, McEwan S. A novel read methodology to evaluate the optimal dose of 68Ga-satoreotide trizoxetan as a PET imaging agent in patients with gastroenteropancreatic neuroendocrine tumours: a phase II clinical trial. EJNMMI Res. 2021 Sep 6;11(1):84. doi: 10.1186/s13550-021-00819-1.