ClinConnect ClinConnect Logo
Search / Trial NCT06957782

The Value of 68Ga-FAPI PET/CT for Evaluating Peritoneal Treatment Response

Launched by ERASMUS MEDICAL CENTER · May 2, 2025

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Peritoneal Metastasis Intraperitoneal Fapi Pet/Ct

ClinConnect Summary

This clinical trial is studying a new imaging method called 68Ga-FAPI PET/CT to see how well it can evaluate the response to a specific type of chemotherapy used for patients with peritoneal metastasis (PM), which is when cancer spreads to the lining of the abdomen. Traditional methods, like CT scans, often miss these metastases, and other options can be invasive. The goal is to find out if 68Ga-FAPI PET/CT can provide a more accurate and non-invasive way to assess how well the treatment is working.

To participate in this trial, individuals must be 18 years or older and plan to start repeated intraperitoneal chemotherapy for visible peritoneal metastases. They should have a good performance status, meaning they can carry out daily activities with little difficulty. However, those with certain health issues, such as severe kidney problems or who are pregnant or breastfeeding, may not be eligible. Participants will undergo the 68Ga-FAPI PET/CT scan, which is a simple procedure that involves lying still while the imaging is done. This study aims to improve how doctors evaluate treatment effectiveness for PM and help patients receive better care.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • A planned start of repeated IP chemotherapy (with or without the combination of systemic chemotherapy) for macroscopic peritoneal metastases;
  • WHO-performance score of 0 to 1;
  • Aged 18 years or older;
  • Written informed consent according to the ICH-GCP and national/local regulations.
  • Exclusion Criteria:
  • Impaired renal function, defined as eGFR \<25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician;
  • Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered;
  • Known allergic reaction to therapeutic radiopharmaceuticals;
  • Inability to lie still on the back for the duration of PET-CT;
  • Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia).

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Patients applied

0 patients applied

Trial Officials

Stijn Koolen, PharmD, PhD

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported