Using PET/CT scans to evaluate treatment in patients with peritoneal cancer
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
Odense University Hospital · NCT06144853
This study is testing if using special scans can help doctors see how well a new treatment for peritoneal cancer is working without needing to do invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Odense, Funen) |
| Trial ID | NCT06144853 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of repeated FDG-PET/CT scans in 16 patients suffering from peritoneal metastasis due to abdominal cancers who are being treated with Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). The study aims to assess the feasibility and effectiveness of these scans in evaluating treatment response, as current methods rely on invasive biopsies. By exploring non-invasive imaging techniques, the study seeks to optimize patient selection and improve response assessment for future treatment strategies. The research is conducted at the Odense PIPAC Center, focusing on a multidisciplinary approach to patient care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically or cytologically proven gastric, pancreatic, colorectal, or ovarian cancer showing clinical evidence of peritoneal metastasis.
Not a fit: Patients undergoing concomitant systemic chemotherapy or those with significant comorbidities that may affect trial participation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for evaluating treatment response in patients with peritoneal cancer, potentially leading to better personalized treatment strategies.
How similar studies have performed: While the use of PET/CT scans in this context is promising, the approach is still relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Odense, Funen
- Odense PIPAC Center — Odense, Funen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Signe Rønsholdt, MD
- Email: signe.r.rasmussen@rsyd.dk
- Phone: 0045 65411857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peritoneal Cancer, Peritoneal Metastases, Peritoneal Carcinomatosis, Abdominal Cancer, PIPAC, Pressurized intraperitoneal aerosol chemotherapy, FDG-PET/CT, Positron Emission Tomography scan