BMJ open · 2026
Evaluating [18F]-AlF-FAPI-74 PET/CT for diagnosis of the unfavourable CMS4 colorectal cancer subtype (FoCus study): protocol for a prospective, observational, proof-of-concept clinical study.
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van Duijvenvoorde Maurice, Kranenburg Onno, van den Bos Myrna, Hagendoorn Jeroen, Roodhart Jeanine M L, Milne Anya N, Te Riele Wouter W, Lange Marilyne M, Swijnenburg Rutger-Jan, Arensman Rene, Verheijen Paul M, Schiphorst Anandi H W, Kool Walter, Ververs Tessa, De Keizer Bart, Lacle Miangela M, Lam Marnix G E H, Elias Sjoerd G
Аннотация
INTRODUCTION: Consensus molecular subtype 4 (CMS4) colorectal cancer (CRC) is characterised by stromal activation, therapy resistance and poor prognosis. Current CMS4 assessment relies on tissue sampling, which is limited by sampling bias due to inter-lesion and intra-lesion heterogeneity. Fibroblast activation protein (FAP) gene-expression is strongly associated with CMS4 status. [18F]-AlF-FAPI-74 positron emission tomography (PET)/ computed tomography (CT) enables non-invasive, whole-body assessment of FAP expression and may therefore provide an imaging-based biomarker for CMS4 status in CRC.
METHODS AND ANALYSIS: FoCus is a prospective, observational proof-of-concept clinical study including 45 patients (≥18 years) with resectable metachronous or synchronous colorectal liver metastases. Eligible patients must have at least one liver metastasis of ≥15 mm scheduled for surgical resection. Patients will undergo [18F]-AlF-FAPI-74 PET/CT prior to clinically indicated therapeutic interventions, including surgical resection of primary tumours and/or metastases and, when applicable, prior to systemic therapy. The primary endpoint is CMS4 status, determined by RNA sequencing of resected tumour tissue using multi-region sampling to account for spatial heterogeneity. Diagnostic performance of FAPI-PET (index test) for CMS4 classification (reference standard) will be evaluated using receiver operating characteristic analysis at the tumour-level. Secondary endpoints include FAP expression assessed by immunohistochemistry and ELISA.
ETHICS AND DISSEMINATION: The study has been approved by the institutional review board NedMec+, the Netherlands (protocol 23-298; Clinical Trials Information System EU CT number: 2023-509183-17-00). All participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER: NCT06191120.
METHODS AND ANALYSIS: FoCus is a prospective, observational proof-of-concept clinical study including 45 patients (≥18 years) with resectable metachronous or synchronous colorectal liver metastases. Eligible patients must have at least one liver metastasis of ≥15 mm scheduled for surgical resection. Patients will undergo [18F]-AlF-FAPI-74 PET/CT prior to clinically indicated therapeutic interventions, including surgical resection of primary tumours and/or metastases and, when applicable, prior to systemic therapy. The primary endpoint is CMS4 status, determined by RNA sequencing of resected tumour tissue using multi-region sampling to account for spatial heterogeneity. Diagnostic performance of FAPI-PET (index test) for CMS4 classification (reference standard) will be evaluated using receiver operating characteristic analysis at the tumour-level. Secondary endpoints include FAP expression assessed by immunohistochemistry and ELISA.
ETHICS AND DISSEMINATION: The study has been approved by the institutional review board NedMec+, the Netherlands (protocol 23-298; Clinical Trials Information System EU CT number: 2023-509183-17-00). All participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER: NCT06191120.