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)

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
GE Healthcare
Study ID
NCT07219238
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
175 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: GEH300079 (68Ga) PET/CT Injection
    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.

Primary Outcome Measure

Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC. [ Time Frame: Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BAMF HealthGrand RapidsMichigan49503-

Find similar trials in Grand Rapids, MI

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
BAMF Health· Grand Rapids, MI

Related Studies