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

Recruiting

• Conditions: Peritoneal Cancer; Peritoneal Metastases; Peritoneal Carcinomatosis; Abdominal Cancer

• Registration Number: NCT06144853
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3

Secondary Outcome Measures

Name	Time	Method
The number of patients with metabolic response after PIPAC 1 according to FDG-PET/CT evaluated by PERCIST 1.0;The number of patients with changed treatment strategy due to extraperitoneal FDG-PET/CT findings after PIPAC 1 or PIPAC 3;The number and reasons for discontinued FDG-PET/CT scans (feasibility);Number of patients with FDG-PET/CT positive peritoneal surface after PIPAC 1 despite negative baseline FDG-PET/CT (false positive/feasibility);The number of patients where FDG-PET/CT evaluated by PERCIST one lesion agrees with histological response according to PRGS after PIPAC 1 and 3