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.
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 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
Single group
GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
DrugAttenuation 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.
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC.
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.
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging and non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging.
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging will be assessed on participants from the ITI using a McNemar test. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging, will be assessed using a restricted maximum likelihood estimate (RMLE) -based score test, with a non-inferiority margin of 10%. SoC images will be reviewed by 3 independent readers. The co-key secondary endpoints will be met if the co-primary endpoints are met and both co-key secondary endpoints are demonstrated for the same reader, for at least 2 of the 3 pairs of readers.
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging in Phase 3
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging will be assessed using a McNemar test, in the Phase 3 part.
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC will be tabulated.
Correlation between radiological and surgical/laparoscopic PCI scores
Correlation between radiological PCI scores (based on GEH300079 (68Ga) PET/CT, CT, MR, \[18F\]FDG PET/CT) and surgical/laparoscopic PCI score.
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GE Healthcare
Lead sponsor
Fortrea
Collaborator
