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

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ClinicalTrials.gov Identifier: NCT03220217
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastro-Enteropancreatic Neuroendocrine Tumor Drug: Satoreotide trizoxetan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All the primary and secondary imaging endpoints are read by third-party independent readers. Most of the reading will be conducted in blinded manner.
Primary Purpose: Diagnostic
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)
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 3, 2020


Arm Intervention/treatment
Experimental: 5-20μg/40-80 MBq, 30-45μg/100-140 MBq
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
Positron emission tomography (PET) imaging agent
Other Name: 68Ga-OPS202

Experimental: 5-20μg/100-140 MBq, 30-45μg/160-200 MBq
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
Positron emission tomography (PET) imaging agent
Other Name: 68Ga-OPS202

Experimental: 5-20μg/160-200 MBq, 30-45μg/40-80 MBq
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
Positron emission tomography (PET) imaging agent
Other Name: 68Ga-OPS202




Primary Outcome Measures :
  1. Difference in relative lesion counts [ Time Frame: Day 1, day 16 to 22 ]
    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 :
  1. Difference in image quality [ Time Frame: Day 1, day 16 to 22 ]
    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, bone and lungs)

  2. Difference in lesion SUVmax [ Time Frame: Day 1, day 16 to 22 ]
    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 in liver, lymph nodes, bone and lungs)

  3. Difference in absolute number of lesions [ Time Frame: Day 1, day 16 to 22 ]
    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

  4. Proportion of subjects experiencing at least one Adverse Event (AE) of any grade [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE v5, 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)

  5. Proportion of subjects experiencing at least one AE of grade ≥3 [ Time Frame: Duration of the study (up to 36 days) ]
    According to NCI CTCAE v5

  6. OPS202 plasma concentration [ Time Frame: Baseline pre-dose (day 0), up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]
  7. Renal excretion of OPS202 in urine [ Time Frame: 0 hours up to 6 hours after 68Ga-OPS202 administration between day 1 and day 22 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220217


Contacts
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Contact: Ipsen Recruitment Enquiries Clinical.trials@ipsen.com

Locations
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United States, California
UCLA Medical Center Completed
Los Angeles, California, United States, 90095
Austria
Medical University of Innsbruck Completed
Innsbruck, Austria, A-6020
University Clinic for Radiology and Nuclear Medicine Completed
Vienna, Austria, A-1090
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, DK-8000
Rigshospitalet, University of Copenhagen Completed
Copenhagen, Denmark, DK-2100
Netherlands
University Medical Center Groningen Hospital Withdrawn
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03220217     History of Changes
Other Study ID Numbers: D-FR-01070-002
2016-004928-39 ( EudraCT Number )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue