Clinical trial · Observational
Resistance Profiling Using Functional Imaging and Next Generation Sequencing in Refractory Gastrointestinal Stomal Tumors (GIST)
Pilot Diagnostic Feasibility Trial of Resistance Profiling Using Functional Imaging and Next Generation Sequencing of Refractory GIST
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor (GIST) | Gastrointestinal Stromal Tumor | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Generation of a comprehensive and single-lesion resistance profile | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility: Number of Patients with a PATHFINDER profile categorization within four weeks
- timeFrame
- 4 weeks
Secondary outcomes (13)
- measure
- Technical feasibility: Turnaround-time required to provide the individual profile
- timeFrame
- 4-8 weeks
- description
- Time in days from patient inclusion to final report of the individual profile
- measure
- Technical Feasibility: Practicality of sample collection
- timeFrame
- 4-8 weeks
- description
- Number of samples collected (blood, tumor) per patient
- measure
- Clinical feasibility: Recruitment and retention rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Previous imaging studies available (CT/MRI/PET Abdomen, ideally at baseline, best response and progression) * ECOG ≤ 2 * Progressing tumor lesion(s) of which one is accessible for biopsy Exclusion Criteria: * contraindication for systemic TKI treatment * contraindication for contrast-enhanced both CT and MRI imaging. * GIST without KIT or PDGFRA mutations * pregnant or breastfeeding women * patient that - to the investigator's discretion - are not able or willing to comply with the provided protocol and visit schemes
References
Publications (0)
Data not yet available