GEH300079 (68Ga) PET/CT scan to detect peritoneal carcinomatosis in colorectal, gastric, ovarian, and pancreatic cancers (PERISCOPE)
A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
This will test whether a GEH300079 (68Ga) PET/CT scan can detect peritoneal carcinomatosis in adults with colorectal, gastric, ovarian, or pancreatic ductal adenocarcinoma who have known or suspected peritoneal disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GE Healthcare Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Grand Rapids, Michigan and 1 other locations) |
| Trial ID | NCT07219238 on ClinicalTrials.gov |
What this trial studies
PERISCOPE is a prospective, multicenter, open-label Phase 2/3 imaging study where participants receive GEH300079 (68Ga) PET/CT in addition to their institutional standard-of-care imaging. The Phase 2 portion will confirm optimal dose and timing and validate assumptions for the Phase 3 portion, while Phase 3 will focus on diagnostic performance in colorectal, gastric, and ovarian primaries with a region-based composite standard of truth. Imaging results will be compared to surgical, histopathologic, and clinical reference data when available, and the pancreatic cancer cohort will be explored in Phase 2. The study is non-randomized and enrolls patients scheduled for peritoneal surgery, exploration, or laparoscopy.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed colorectal, gastric, ovarian cancer, or pancreatic ductal adenocarcinoma who have known or suspected peritoneal carcinomatosis and are scheduled for peritoneal surgery, exploration, or laparoscopy with ECOG performance status ≤2 are the ideal candidates.
Not a fit: Pregnant or breastfeeding patients, people without suspected peritoneal disease or not undergoing surgical exploration, and those with poor performance status (ECOG >2) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this imaging agent could improve detection of peritoneal carcinomatosis and help guide surgical planning and treatment choices.
How similar studies have performed: Early clinical work with FAPI-based 68Ga PET tracers has shown promising sensitivity for peritoneal disease, but large prospective phase 3 confirmation across multiple tumor types remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 the tumor of origin. Suspicion may be based on imaging or clinical findings. * Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET/CT Imaging Visit * Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Participant is able and willing to comply with all study procedures as described in the protocol Exclusion Criteria: * Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP) * Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures * Participant needs any intervention that would delay study participation * Participant has non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work up * Participant will not be able to complete the study, based on their anticipated life expectancy * Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted) * Participant has renal function impairment as defined by: 1. For Phase 2: estimated glomerular filtration rate less than 60 mL/min 2. For Phase 3: estimated glomerular filtration rate less than 30 mL/min * Participant has severe hepatic function impairment as defined by: 1. Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases) 2. Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN * Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed * Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives * Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period) * Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga) * Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason * (Phase 3 only) Participant was previously included in Phase 2 of this study
Where this trial is running
Grand Rapids, Michigan and 1 other locations
- BAMF Health — Grand Rapids, Michigan, United States (Not_yet_recruiting)
- Karolinska Universitetssjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Michelle Straszacker
- Email: michelle.straszacker@gehealthcare.com
- Phone: +44 7827 845147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.