FAPI PET/CT imaging to help diagnose CMS4 colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses an advanced FAPI PET/CT imaging agent to visualize tumor biology in patients with metastatic colorectal cancer, particularly those with involvement of the liver. The goal is to see if imaging patterns correlate with the CMS4 molecular subtype, which is linked to poorer prognosis and different treatment responses. Eligible participants are adults scheduled for liver metastasis surgery, with at least one liver lesion 1.5 cm or larger. Prior treatments are allowed, as the focus is on real-time CMS4 status at the time of imaging and surgery. The study is conducted at University Medical Center Utrecht under the lead sponsor, with imaging data guiding potential future CMS4-targeted approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Candidates for liver metastatectomy at the time of liver metastasis diagnosis as clinically indicated in the tumor board (RAKU).
* Patients must have given written informed consent.
* At least one liver metastasis should have a longest diameter of a least 1.5 cm as measured on routinely performed imaging (e.g. magnetic resonance imaging, CT-scan or ultrasound). This minimum diameter will guarantee sufficient tissue material for analysis and will prevent underestimation of \[18F\]-ALF-FAPI-74 uptake due to partial volume effects.
* CRC patients who received prior treatment before clinical indication for surgical liver metastases resection (both synchronous and metachronous patients, as well as a re-resection of liver metastatic disease) are allowed to enter the study. This is because our prime interest is in the relation between FAPI uptake and the presence of CMS4 at the same point in time, which will likely not be biased by earlier therapies.
* It is allowed for patients to receive concurrent radiofrequency ablation or other local treatments directed to other metastatic disease locations, if at least one liver metastasis of sufficient size is planned to be surgically removed and therefore available for tissue analysis.
* It is allowed for patients to be treated with pre-surgical radiotherapy directed to the primary tumor (e.g. in rectal cancer patients).

Exclusion Criteria:

* Pregnancy.
* Patients treated with a pre-surgical chemotherapy regimen that does not include a fluoropyrimidine.

Where it's running

• University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: M. G.E.H. Lam — UMC Utrecht
• Study coordinator: M. van Duijvenvoorde
• Email: m.vanduijvenvoorde@umcutrecht.nl
• Phone: +31 088 75 56474

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.