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NCT03220217 · ClinicalTrials.gov registry record · Phase 2
To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
A Phase 2 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT03220217: Completed Phase 2 study, sponsored by Ipsen.
NCT03220217 is a Phase 2 study that has completed, run by Ipsen. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03220217, a Phase 2 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Satoreotide trizoxetan 5-20μg
- DRUG Satoreotide trizoxetan 30-45μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 2 |
What the finished NCT03220217 record still lists
NCT03220217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Satoreotide trizoxetan 5-20μg is the first listed.
NCT03220217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03220217 about?
NCT03220217 is a clinical study titled "To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)". 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 agen...
What is the current status of trial NCT03220217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2017-09-26. Estimated completion is 2019-08-05.
What interventions are being tested in trial NCT03220217?
The interventions under investigation include: Satoreotide trizoxetan 5-20μg (DRUG), Satoreotide trizoxetan 30-45μg (DRUG).
Who is sponsoring clinical trial NCT03220217?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03220217's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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