The PIPAC-OPC7 Study: The Use of PET/CT Scans as a Method of Evaluation in Patients Treated With … (NCT06144853) | Clinical Trial Compass
CompletedNot Applicable
The PIPAC-OPC7 Study: The Use of PET/CT Scans as a Method of Evaluation in Patients Treated With PIPAC, a Pilot Study.
Denmark34 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3