Actively Recruiting
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)
Led by GE Healthcare · Updated on 2026-05-05
175
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
Sponsors
G
GE Healthcare
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older
- Participant has signed informed consent before any study-specific screening procedures
- Participant has histopathologically confirmed primary colorectal, gastric, ovarian cancer, or pancreatic ductal adenocarcinoma
- Participant has known or suspected Peritoneal Carcinomatosis from the primary tumor based on imaging or clinical findings
- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy either without prior treatment or after systemic treatment including neoadjuvant chemotherapy
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Participant is willing and able to comply with all study procedures as described in the protocol
You will not qualify if you...
- Participant is pregnant, breastfeeding, or sexually active without using acceptable birth control from screening to 30 days after receiving the investigational product
- Participant has a disorder that may impact study procedures as judged by the investigator
- Participant requires any intervention that would delay study participation
- Participant has non-resectable extra-abdominal metastasis or more than 3 liver metastases on standard work up
- Participant is not expected to complete the study due to limited life expectancy
- Participant has active bacterial, viral, or fungal infection requiring systemic treatment (topical treatments allowed)
- Participant has renal impairment with estimated glomerular filtration rate less than 60 mL/min for Phase 2 or less than 30 mL/min for Phase 3
- Participant has severe liver function impairment defined by specific enzyme and bilirubin levels
- Participant has autoimmune disease requiring systemic treatment within the past 2 years (replacement therapy allowed)
- Participant has serious co-morbidities or non-malignant disease compromising safety or protocol goals
- Participant has received or plans to receive any other investigational agent within 28 days before imaging or during the study (except during 3-month follow-up)
- Participant is known or suspected to be allergic to any excipients in GEH300079 (68Ga)
- Participant has severe claustrophobia, cannot lie flat, fit in the scanner, or tolerate the PET/CT scan
- Participants in Phase 3 who were previously included in Phase 2 of this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
BAMF Health
Grand Rapids, Michigan, United States, 49503
Not Yet Recruiting
2
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
M
Michelle Straszacker
CONTACT
A
Aimee Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here