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Search / Trial NCT06144853

The PIPAC-OPC7 Study: The Use of PET/CT Scans as a Method of Evaluation in Patients Treated With PIPAC, a Pilot Study.

Launched by ODENSE UNIVERSITY HOSPITAL · Nov 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pipac Pressurized Intraperitoneal Aerosol Chemotherapy Fdg Pet/Ct Positron Emission Tomography Scan Response Evaluation

ClinConnect Summary

The PIPAC-OPC7 study is a clinical trial designed to explore the use of special imaging scans called FDG-PET/CT scans in patients with cancer that has spread to the lining of the abdomen, a condition known as peritoneal metastasis. This study will involve 16 patients who are receiving a type of treatment called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). The goal is to see if these scans can effectively evaluate how well the treatment is working and to determine if this method is practical for patients.

To be eligible for this trial, participants must be adults over 18 years old with specific types of cancer that have spread to the abdomen and must have a maximum of one other area of cancer outside the abdomen. They should also be in good general health, able to provide consent in Danish, and not currently undergoing other systemic chemotherapy. Participants will receive the PIPAC treatment and have repeated scans to monitor their progress throughout the study. This trial is currently recruiting participants who meet these criteria, and it aims to improve how we assess treatment effectiveness in patients with challenging abdominal cancers.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with synchronous or metachronous histology or cytology proven GC, PC, CRC, or OC with clinical evidence of PM.
  • Patients who are eligible for and offered PIPAC at the discretion of the dedicated multidisciplinary tumor conference and subsequent out-patient evaluation at Odense PIPAC Center
  • Patients with a maximum of one extra-peritoneal metastasis at CT dated within one month of inclusion.
  • Patients in Eastern Cooperative Oncology Group performance status 0-1.
  • Patients \>18 years of age.
  • Patients must be able to give mandatory oral and written consent in Danish.
  • Exclusion Criteria:
  • Concomitant systemic chemotherapy (bidirectional treatment).
  • Known allergies to contrast dye.
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or may influence the results.

About Odense University Hospital

Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.

Locations

Odense, Funen, Denmark

Patients applied

0 patients applied

Trial Officials

Michael B Mortensen, Professor

Study Director

Odense PIPAC Center, Department of Surgery, Odense University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported