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GEH300079 · 1 trial · 4 indications
The co-primary efficacy endpoint is based on region level sensitivity and specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC in participants with colorectal, gastric or ovarian primary cancer. GEH300079 (68Ga) PET/CT images collected during the Phase 2 part will be reviewed by 5 independent readers. Images collected during the Phase 3 part will be reviewed by 3 readers. The superiority of per region sensitivity (respectively specificity) to a pre-specified threshold of 75% (respectively 70%) will be assessed using one-sided Z-tests. The co-primary endpoints will be considered as met if superiority of both per region sensitivity and per region specificity is achieved by at least 3 of the 5 readers in the Phase 2 part, and by at least 2 of the 3 readers in the Phase 3 part.
| Arm | Type | Description |
|---|---|---|
| GEH300079 (68Ga) PET/CT Injection | EXPERIMENTAL | Single IV bolus of GEH300079 (68Ga), target activity 3.6 MBq/kg (150-300 MBq). PET/CT scan at 60 ±5 min post-dose (vertex to mid-thigh, \~20-30 min). Phase 2 subset: additional scans at 15 ±5 min and 3 h ±10 min. |
| Name | Type | Description |
|---|---|---|
| GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) | DRUG | Attenuation correction CT will commence after the administration of GEH300079 (68Ga), and immediately before the PET acquisition. The PET acquisition will encompass the participant's vertex through mid-thighs. Images will be acquired at 60 ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. |
Inclusion Criteria: * Participant is ≥18 years of age * Participant has provided signed informed consent before any study-specific screening procedures * Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC * Participant has known or suspected PC from ...
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GEH300079 is an investigational small molecule PET imaging agent developed by GE HealthCare Technologies Inc. (ticker GEHC). It is being studied as GEH300079 (68Ga) Injection for use with positron emission tomography and computed tomography, known as PET/CT, to help detect certain cancers. It is in Phase 2 clinical development and is not approved.
GEH300079 is being evaluated for the detection of colorectal cancer using PET/CT imaging. The Phase 2 PERISCOPE study is testing its diagnostic performance in patients with colorectal, gastric, ovarian, or pancreatic cancers. It is an investigational imaging agent and has not been approved for clinical use.
GEH300079 is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is sponsoring the Phase 2 PERISCOPE trial evaluating the agent for PET/CT detection of colorectal, gastric, ovarian, and pancreatic cancers.
GEH300079 is in Phase 2 clinical development. It is an investigational agent and is not FDA approved. The only registered study of GEH300079 is a Phase 2 diagnostic performance trial that is currently recruiting participants.
GEH300079 is being studied in the Phase 2 PERISCOPE trial, registered as NCT07219238. The study is evaluating the diagnostic performance of GEH300079 (68Ga) Injection PET/CT for detection of cancers in patients with colorectal, gastric, ovarian, or pancreatic tumors. It is recruiting 175 participants across the United States and Sweden.