Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06957782

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

Peritoneal metastases (PM), commonly originating from gastrointestinal and ovarian cancers, are associated with a poor prognosis and limited treatment options due to the diffuse nature of the disease and the inability of systemic chemotherapy to adequately penetrate the peritoneal surface. Intraperitoneal (IP) chemotherapy has emerged as a potential treatment modality for patients with extensive PM, allowing for higher local drug concentrations while minimizing systemic toxicity. However, current response evaluation methods, such as CT scans, have low sensitivity for detecting PM, and second-look laparoscopy, although more accurate, is invasive and unsuitable for repeated assessments. The ⁶⁸Ga-FAPI PET/CT scan offers a promising non-invasive alternative for assessing peritoneal response to IP chemotherapy. This imaging technique targets the fibroblast activation protein, which is overexpressed in cancer-associated fibroblasts within the tumor microenvironment. Early studies have shown that ⁶⁸Ga-FAPI PET/CT is a highly sensitive too in detecting peritoneal metastases. Given these advantages, the investigators hypothesize that ⁶⁸Ga-FAPI PET/CT could improve the evaluation of treatment response in patients undergoing IP chemotherapy for PM, offering a non-invasive and accurate alternative to current methods. The primary objective of this study is to investigate the accuracy of ⁶⁸Ga-FAPI PET/CT for evaluating peritoneal response in patients with peritoneal metastases undergoing repeated IP chemotherapy.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

⁶⁸Ga-FAPI-46

Drug

All patients will be administered with 1.5 MBq/kg ⁶⁸Ga-FAPI-46. ⁶⁸Ga-FAPI-46 will be injected intravenously followed by a flush injection of 10 mL of saline following routine procedures.

Primary outcomes

  1. Accuracy of ⁶⁸Ga-FAPI

    Time frame: 18 weeks

    To investigate the accuracy of the ⁶⁸Ga-FAPI PET/CT for peritoneal response evaluation in patients with peritoneal metastases that are treated with any form of repeated IP chemotherapy. The accuracy will be calculated as the sensitivity and specificity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as a reference standard.

Secondary outcomes

  1. Tumor response to IP chemotherapy

    Time frame: 18 weeks

    To measure the tumor response to IP chemotherapy. The absolute change in peritoneal tumor size or volume as measured by imaging before and after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Micha de Neijs

CONTACT

[email protected]

+31 10 70 39640

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: INTERACT-FAPI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 5, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.