GEH300079 (68Ga) PET/CT scan to detect peritoneal carcinomatosis in colorectal, gastric, ovarian, and pancreatic cancers (PERISCOPE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Karolinska Universitetssjukhuset
  Stockholm, Sweden Recruiting
• BAMF Health
  Grand Rapids, Michigan, United States Not yet recruiting

Study contacts

• Study coordinator: Michelle Straszacker
• Email: michelle.straszacker@gehealthcare.com
• Phone: +44 7827 845147

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• IBI3028 in advanced solid tumors

  This phase 1 study tests IBI3028 in adults with unresectable or metastatic solid tumors to see if it is safe and how patients tolerate it.

  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

• PET scan using [18F]FPyQCP to image fibroblast activation protein in several cancers

  This test tries a new PET imaging tracer, [18F]FPyQCP, to see if it helps detect colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, and epithelial ovarian cancers in adults.

  Recruiting Phase 1/2 Blue Earth Diagnostics · New York, New York and 1 other locations · NCT07432633

• Targeted radioligand [177Lu]Lu-DFC413 for advanced pancreatic, lung, breast, and colorectal cancers

  This will test a new targeted radioactive medicine, [177Lu]Lu-DFC413 (with a PET tracer [68Ga]Ga-NNS309), to see if it is safe and shows activity in adults with advanced pancreatic, lung, breast, or colorectal cancer.

  Recruiting at 9 sites Phase 1 Novartis · Princeton, New Jersey and 8 other locations · NCT07261631

• Finding a suitable dose of ASP5834 for adults with solid tumors

  This trial tests different doses of the experimental drug ASP5834, given alone or with panitumumab, in adults whose advanced solid tumors have certain KRAS mutations to find a safe, tolerable dose.

  Recruiting at 22 sites Phase 1 Astellas Pharma Inc · Santa Monica, California and 21 other locations · NCT07094204

• VS-7375 for adults with KRAS G12D-mutated advanced solid tumors.

  This trial tests VS-7375, alone and combined with other cancer drugs, in adults with unresectable or metastatic solid tumors that have the KRAS G12D mutation.

  Recruiting at 22 sites Phase 1/2 Verastem, Inc. · Los Angeles, California and 21 other locations · NCT07020221

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.