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NCT07109024

Resistance Profiling Using Functional Imaging and Next Generation Sequencing in Refractory Gastrointestinal Stomal Tumors (GIST)

Sponsor: Universität Duisburg-Essen

View on ClinicalTrials.gov

Summary

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.

Official title: Pilot Diagnostic Feasibility Trial of Resistance Profiling Using Functional Imaging and Next Generation Sequencing of Refractory GIST

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2031-03

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Generation of a comprehensive and single-lesion resistance profile

AI-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.

Locations (2)

University Hospital Essen

Essen, Germany

University Hospital Schleswig-Holstein, Dpt. of Hematlogy and Oncology

Lübeck, Germany