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

NCT06144853 | Completed

• 1 other identifier: PIPAC_OPC7
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Cancer; Abdominal Cancer; Peritoneal Metastases; Peritoneal Carcinomatosis

Keywords

PIPAC; Pressurized intraperitoneal aerosol chemotherapy; FDG-PET/CT; Positron Emission Tomography scan; response evaluation

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (5)

• 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

Interventions

scan OTHER

Fluorodeoxyglucose (FDG)-positron emission tomography/Computed tomography scan

Eligibility Criteria

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

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense PIPAC Center

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Michael B Mortensen, Professor

  Odense PIPAC Center, Department of Surgery, Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 22, 2023
• Study Start: March 15, 2024
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)