To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | September 20, 2017 |
| End Date: | March 3, 2020 |
| Contact: | Ipsen Recruitment Enquiries |
| Email: | Clinical.trials@ipsen.com |
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)
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.
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.
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)
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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