To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

NCT03220217 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: D-FR-01070-0022016-004928-39
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 5

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.

Conditions

Gastro-Enteropancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (2)

• Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges

  For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.

  Day 1 and Days 16 to 22

• Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges

  For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.

  Day 1 and Days 16 to 22

Secondary Outcomes (9)

• Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range

  Day 1 and Days 16 to 22

• Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges

  Day 1 and Days 16 to 22

• Image Quality as Assessed by Independent Blinded Readers Quality Score

  Day 1 and Days 16 to 22

• Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges

  Day 1 and Days 16 to 22

• Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges

  Day 1 and Days 16 to 22

Study Arms (3)

5-20μg/40-80 MBq, 30-45μg/100-140 MBq

EXPERIMENTAL

Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.

Drug: Satoreotide trizoxetan 5-20μg; Drug: Satoreotide trizoxetan 30-45μg

5-20μg/100-140 MBq, 30-45μg/160-200 MBq

EXPERIMENTAL

Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.

Drug: Satoreotide trizoxetan 5-20μg; Drug: Satoreotide trizoxetan 30-45μg

5-20μg/160-200 MBq, 30-45μg/40-80 MBq

EXPERIMENTAL

Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.

Drug: Satoreotide trizoxetan 5-20μg; Drug: Satoreotide trizoxetan 30-45μg

Interventions

Satoreotide trizoxetan 5-20μg DRUG

Positron emission tomography (PET) imaging agent

Also known as: 68Ga-OPS202 5-20μg, 68Ga-IPN01070 5-20μg

5-20μg/100-140 MBq, 30-45μg/160-200 MBq; 5-20μg/160-200 MBq, 30-45μg/40-80 MBq; 5-20μg/40-80 MBq, 30-45μg/100-140 MBq

Satoreotide trizoxetan 30-45μg DRUG

Positron emission tomography (PET) imaging agent

Also known as: 68Ga-OPS202 30-45μg, 68Ga-IPN01070 30-45μg

5-20μg/100-140 MBq, 30-45μg/160-200 MBq; 5-20μg/160-200 MBq, 30-45μg/40-80 MBq; 5-20μg/40-80 MBq, 30-45μg/100-140 MBq

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (5)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Medical University of Innsbruck

Innsbruck, A-6020, Austria

Location

University Clinic for Radiology and Nuclear Medicine

Vienna, A-1090, Austria

Location

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Rigshospitalet, University of Copenhagen

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34487283 DERIVED

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Limitations and Caveats

In each injected peptide/radioactivity dose combination for outcome measures 1, 3 and 6, the number of subjects with lesions in the primary site of GEP-NET, bone and lung was too small (0 to 3) to allow for a meaningful interpretation of the results. Similarly, in each category of peptide mass range and radioactivity dose range for outcome measures 2, 4 and 7, the number of subjects with lesions in bone and lung was too small (0 to 2) to allow for a meaningful interpretation of the results.

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

See email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 18, 2017
• Study Start: September 26, 2017
• Primary Completion: July 25, 2019
• Study Completion: August 5, 2019
• Last Updated: January 14, 2021
• Results First Posted: January 14, 2021

Record last verified: 2021-01

Locations

US (1); DK (2); AU (2)