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GEH300079 (68Ga) PET/CT for Detecting Peritoneal Carcinomatosis

This study is testing a new imaging method, GEH300079 (68Ga) Injection PET/CT, to see how well it can detect peritoneal carcinomatosis (PC). PC is when cancer spreads to the lining of the abdomen. You might be able to join if you are 18 or older and have colorectal, gastric, ovarian, or pancreatic cancer that is known or suspected to have spread to the peritoneum. The study will measure how accurately GEH300079 (68Ga) PET/CT can find these cancer cells. The goal is to see if this new imaging technique can improve detection of PC. The current status of this study is unclear, and it aims to enroll 175 participants.

Study design
This is a Phase 2/3, multicenter, open-label, non-randomized clinical trial. It plans to enroll 175 participants.
What's involved
You would receive an injection of GEH300079 (68Ga) followed by a PET/CT scan about 60 minutes later. The scan itself will take approximately 20 to 30 minutes.
Compensation
Not stated in the trial record.
Follow-up
Images will be acquired at a single time point, 60 minutes (±5 minutes) post injection.

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NCT07219238

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)

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
GE Healthcare
~175 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC.
Measured over Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

Conditions

Colorectal Cancer
Gastric Cancers
Ovarian Cancers
Pancreatic Ductal Adenocarcinoma

Explore related trials

Colorectal CarcinomaGastric CarcinomaMalignant Ovarian NeoplasmPancreatic Ductal AdenocarcinomaPeritoneal Carcinomatosis

Where it's being run

2 sites across 2 states
Michigan1
Sweden1

Who to contact

Michelle Straszacker
[email protected]
+44 7827 845147
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
Participant has severe hepatic function impairment as defined by:
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

What this trial measures

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

    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.