Gastrointestinal stromal tumors (GIST) are the most common malignant sarcomas of the gastrointestinal tract. Inhibitors of the mutated driver proteins KIT and PDGFRA can temporarily control disseminated GIST disease but cannot cure it. Recently, the investigators were able to elucidate the two main resistance mechanisms-the coexistence of ATP-binding pocket (AP) and activation loop (AL) mutations, as well as AP/AL combination mutations. Determining these resistance factors requires methods that are not yet established in routine clinical practice. The investigators hypothesize that identifying these factors and creating resistance profiles in the context of the anatomical location of metastatic lesions can open up new, clinically relevant therapeutic options, including local therapies. The aim of this project is to evaluate the practicability of these methods in everyday clinical use. An AI-supported image analysis and specialized molecular methods will be combined into a comprehensive resistance profile and will be provided to the treating physicians to potentially guide treatment decisions.
Advanced gastrointestinal stromal tumors history of exposure and progression or intolerance to imatinib, sunitinib, regorafenib and ripretinib
Clinical indication for PET-CT and tumor biopsy (optional) (sarcoma center tumorboard protocol)
Age 18 years and older
FFPE tumor tissue available
contraindication for systemic TKI treatment
contraindication for contrast-enhanced both CT and MRI imaging.
GIST without KIT or PDGFRA mutations
pregnant or breastfeeding women
Patients with advanced gastrointestinal stromal tumors history of exposure and progression or intolerance to imatinib, sunitinib, regorafenib and ripretinib
Cohort
Prospective
Generation of a comprehensive and single-lesion resistance profile
Diagnostic testAI-supported image analysis of functional imaging (PET-CT) and previous imaging data and specialized molecular methods (next-generation sequencing) will be combined into a comprehensive resistance profile.
Feasibility: Number of Patients with a PATHFINDER profile categorization within four weeks
Technical feasibility: Turnaround-time required to provide the individual profile
Time in days from patient inclusion to final report of the individual profile
Technical Feasibility: Practicality of sample collection
Number of samples collected (blood, tumor) per patient
Clinical feasibility: Recruitment and retention rate
Numer of patients recruited within two years and percentage of patients completing follow-up according to the protocol.
Clinical feasibility: Adherence to the diagnostic protocol
Percentage of patients in which all diagnostic tests have been successfully performed.
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Universität Duisburg-Essen
Lead sponsor
University Hospital Münster, Insitute of Pathology
Collaborator
University Hospital Schleswig-Holstein
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
