Clinical Trials /

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

Description:

The purpose of this clinical research is to define the optimal dose of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-OPS202 is made of two main components: 1) OPS202, 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 OPS202 can be seen in the PET scanner.

Related Conditions:
  • Colon Neuroendocrine Neoplasm
  • Duodenal Neuroendocrine Tumor
  • Esophageal Neuroendocrine Tumor
  • Gastric Neuroendocrine Tumor
  • Gastrointestinal Neuroendocrine Tumors
  • Pancreatic Neuroendocrine Tumor
  • Rectal Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: D-FR-01070-002
  • SECONDARY ID: 2016-004928-39
  • NCT ID: NCT03220217

Conditions

  • Gastro-Enteropancreatic Neuroendocrine Tumor

Interventions

DrugSynonymsArms
68Ga-OPS2025-20μg/40-80 MBq, 30-45μg/100-140 MBq

Purpose

The purpose of this clinical research is to define the optimal dose of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-OPS202 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-OPS202 is made of two main components: 1) OPS202, 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 OPS202 can be seen in the PET scanner.

Trial Arms

NameTypeDescriptionInterventions
5-20μg/40-80 MBq, 30-45μg/100-140 MBqExperimentalSubjects will receive a first intravenous (i.v.) injection of 68Ga-OPS202 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 68Ga-OPS202 with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.
  • 68Ga-OPS202
5-20μg/100-140 MBq, 30-45μg/160-200 MBqExperimentalSubjects will receive a first i.v. injection of 68Ga-OPS202 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 68Ga-OPS202 with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.
  • 68Ga-OPS202
5-20μg/160-200 MBq, 30-45μg/40-80 MBqExperimentalSubjects will receive a first i.v. injection of 68Ga-OPS202 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 68Ga-OPS202 with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.
  • 68Ga-OPS202

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

          -  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, or bone

          -  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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Difference in relative lesion counts
Time Frame:Day 1, day 16 to 22
Safety Issue:
Description:For each combination of injected peptide/radioactivity dose range, differences in relative lesion counts derived from a 2 × 3 factorial analysis measuring the ratio of the number of lesions detected by 68Ga-OPS202 to the number of lesions assessed by standard-of-truth (descriptive analyses). The standard-of-truth in this study is the CT scan images acquired at Visit 2 (day 1 and Visit 3 (day 16 to 22).

Secondary Outcome Measures

Measure:Difference in image quality
Time Frame:Day 1, day 16 to 22
Safety Issue:
Description:For each combination of injected peptide/radioactivity dose range, differences in image quality derived from a 2 × 3 factorial analysis measuring the tumour-to-background ratio in each of the major anatomic sites (i.e., descriptive analyses for liver, lymph nodes and bone)
Measure:Difference in lesion SUVmax
Time Frame:Day 1, day 16 to 22
Safety Issue:
Description:Differences in lesion SUVmax between the two peptide mass dose ranges and the three radioactivity dose ranges measured in the most avid lesions (descriptive analyses for up to a maximum of five lesions per organ)
Measure:Difference in absolute number of lesions
Time Frame:Day 1, day 16 to 22
Safety Issue:
Description:Differences of absolute number of lesions between the two peptide mass dose ranges and the three radioactivity dose ranges detected in each of the following anatomic sites: Primary site of GEP-NET, Lymph nodes, Liver, Axial/ appendicular skeleton and Lungs
Measure:Proportion of subjects experiencing at least one Adverse Event (AE) of any grade
Time Frame:Duration of the study (up to 36 days)
Safety Issue:
Description:According to NCI CTCAE v4.03, including any Serious Adverse Events (SAEs) and suspected unexpected serious adverse reactions (SUSARs). All AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term (PT) (as per most recent version)
Measure:Proportion of subjects experiencing at least one AE of grade ≥3
Time Frame:Duration of the study (up to 36 days)
Safety Issue:
Description:According to NCI CTCAE
Measure:OPS202 plasma concentration
Time Frame:Baseline pre-dose (day 0), up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22
Safety Issue:
Description:
Measure:Renal excretion of OPS202 in urine
Time Frame:0 hours up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ipsen

Last Updated

April 27, 2018