FAPI Molecular Imaging for Diagnosis of the CMS4 Unfavorable Colorectal Cancer Subtype

Plain-language summary

This study investigates the use of [18F]-ALF-FAPI-74 PET/CT imaging to identify the unfavorable CMS4 subtype of colorectal cancer. It enrolls colorectal cancer patients aged 18 and older who have liver metastases planned for surgical removal. It is a study without a designated phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

UMC Utrecht

Intervention

[18F]-ALF-FAPI-74 PET/CT scan

Start date

8/5/2024

Estimated completion

7/1/2031

Countries

Netherlands

Related genes

Locations

• Utrecht, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.