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)

NCT07219238 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: GE-282-201IND:1519012024-519384-18-00
• Study Type: interventional
• Target: 175
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Colorectal Cancer; Gastric Cancers; Ovarian Cancers; Pancreatic Ductal Adenocarcinoma

Keywords

Peritoneal Carcinomatosis (PC); Pancreatic Cancers; Colorectal cancer; Gastric cancer; FAPI; Ovarian cancer; 68Ga; PET/CT imaging; Diagnostic imaging; Diagnostic performance

Outcome Measures

Primary Outcomes (1)

• 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.

  Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

Secondary Outcomes (21)

• 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.

  Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

• Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging in Phase 3

  Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

• 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

  Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

• Correlation between radiological and surgical/laparoscopic PCI scores

  Single time point. Baseline SoC images. GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection

• The number of Positive peritoneal regions and percentage of participants with a difference in the number of Positive peritoneal regions.

  single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

Study Arms (1)

GEH300079 (68Ga) PET/CT Injection

EXPERIMENTAL

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.

Drug: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)

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.

GEH300079 (68Ga) PET/CT Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• For Phase 2: estimated glomerular filtration rate less than 60 mL/min
• For Phase 3: estimated glomerular filtration rate less than 30 mL/min
• Participant has severe hepatic function impairment as defined by:
• 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)
• 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)

Sponsors & Collaborators

• GE Healthcare: lead
• Fortrea: collaborator

Study Sites (2)

BAMF Health

Grand Rapids, Michigan, 49503, United States

NOT YET RECRUITING

Karolinska Universitetssjukhuset

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Peritoneal Diseases; Pancreatic Diseases

Central Study Contacts

Michelle Straszacker

CONTACT

+44 7827 845147; michelle.straszacker@gehealthcare.com

Aimee Liu

CONTACT

617-505-2861; Aimee.Liu@gehealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: An independent, blinded read of the GEH300079 (68Ga) PET/CT and baseline SoC images will be performed at a central location (offsite) by independent readers blinded to the study information except the primary tumor site.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 21, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1); SE (1)