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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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