The PIPAC PET Pilot Study, OPC-7

FDG-PET/CT as a Method of Patient Selection and Response Evaluation in Patients With Peritoneal Metastasis Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy. A Pilot Study

The pilot study will investigate the use of repeated FDG-PET/CT scans in 16 patients with peritoneal metastasis originating from abdominal cancers treated with Pressurized Intraperitoneal Aerosol Chemotherapy. The study will focus on the potential of repeated FDG-PET/CT scans to evaluate the treatment as well as the feasibility in the patient group.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Cancer; Peritoneal Carcinomatosis; Peritoneal Cancer; Peritoneal Metastases
• Intervention / Treatment: Other: scan

Detailed Description

Background: Peritoneal metastasis (PM) is a late-stage manifestation of several gastro-intestinal cancers. Conventional administrated chemotherapy has limited effect due to the peritoneal-plasma barrier and most patients will die from their disease within a few months. An alternative treatment strategy, Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC), has gained interest in the last decade. Prospective phase II studies have demonstrated significant local treatment effect and promising survival data initially within the palliative setting but more recently also with curative intent. The technical aspects of PIPAC are nearly uniform worldwide but there is no consensus on the optimal evaluation of treatment response. Currently, histological features in repeated biopsies from the peritoneum are used as an indicator of treatment response. Thus, easily accessible, and non-invasive alternatives are needed to optimize and personalize patient selection and to improve the response assessment. Both are also essential regarding future development and implementation of this treatment for both curative and palliative purposes. This could be achieved with the use of imaging techniques. Computed tomography (CT) scan holds well-known limitations in the detection of PM. Alternatively, several studies have investigated the use of the Positron emission tomography and CT (PET/CT) scans in the diagnostic setting of PM. This method shows promising results concerning visualization and assessing PM lesions, but no studies have investigated the ability of PET/CT scans to detect changes in PM during PIPAC treatment. Enabling the use of PET/CT scans as an evaluation tool for PIPAC-directed therapy is an important and necessary step to expand the clinical application. Also, non-invasive evaluation methods and consensus of evaluation is of significant importance for the quality of future randomized controlled trials in this field of research. We want to conduct a prospective study to investigate if PET/CT scans can detect changes within PM lesions in patients treated with PIPAC directed therapy. Since the study is the first of its kind, we plan to start with a pilot study including only a few patients. We will use the results to generate important knowledge for subsequent larger randomized studies on and clinical optimization of PIPAC directed therapy in patients with PM.

Objective: To investigate whether FDG-PET/CT scans can detect changes in PM in patients treated with PIPAC and whether the repeated scans are feasible within this group of patients.

Method: The pilot study will include 16 patients with known PM, four from each of the groups: gastric cancer, pancreatic cancer, colo-rectal cancer and ovarian cancer will be included. The patient will be offered standard PIPAC directed treatment (including standard histological evaluation of biopsies of the peritoneum) according to local guidelines. During the first series (one series is equivalent to three PIPAC treatments each five weeks) patients will receive three FDG-PET/CT's, one before PIPAC 1, one after PIPAC 2 and one after PIPAC 3. The scans will be described according to PERCIST (PET response criteria in solid tumors). In case of FDG-negative PM-disease at the first scan the patient will receive only one follow-up scan after PIPAC 2 to investigate whether the treatment if self can cause FDG-uptake in the PM elements.

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: Signe Rønsholdt, MD; Phone Number: 0045 65411857; Email: signe.r.rasmussen@rsyd.dk
• Study Contact Backup: Name: Michael B Mortensen, Professor; Phone Number: 0045 65411857; Email: michael.m.mortensen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

16 patients with peritoneal metastasis, four from each of the groups: gastric cancer, pancreatic cancer, colo-rectal cancer and ovarien cancer, eligebel for inclusion in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients with metabolic response after PIPAC 1 according to FDG-PET/CT evaluated by PERCIST 1.0	18 months
The number of patients with changed treatment strategy due to extraperitoneal FDG-PET/CT findings after PIPAC 1 or PIPAC 3	18 months
The number and reasons for discontinued FDG-PET/CT scans (feasibility)	18 months
Number of patients with FDG-PET/CT positive peritoneal surface after PIPAC 1 despite negative baseline FDG-PET/CT (false positive/feasibility)	18 months
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	18 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Director: Michael B Mortensen, Professor, Odense PIPAC Center, Department of Surgery, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: FDG-PET/CT; PIPAC; Pressurized intraperitoneal aerosol chemotherapy; response evaluation; Positron Emission Tomography scan
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Neoplastic Processes; Abdominal Neoplasms; Carcinoma; Neoplasm Metastasis; Peritoneal Neoplasms
• Other Study ID Numbers: PIPAC_OPC7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publications and presentations will be based on patient data, but the database is not open to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No