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NCT07219238 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
A Phase 2 study, sponsored by GE Healthcare.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT07219238 is a Phase 2 study that is actively recruiting participants, run by GE Healthcare. The registered enrollment target is 175 participants.
The verdict
NCT07219238, a Phase 2 study, is actively recruiting participants, sponsored by GE Healthcare.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study Summary
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study. The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.
Interventions
- DRUG GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2026-10 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219238
The ClinicalTrials.gov registry entry for NCT07219238 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) is the first listed.
NCT07219238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07219238 about?
NCT07219238 is a clinical study titled "Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)". This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcino...
What is the current status of trial NCT07219238?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2026-10. Estimated completion is 2029-08.
What interventions are being tested in trial NCT07219238?
The interventions under investigation include: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) (DRUG).
Who is sponsoring clinical trial NCT07219238?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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