Clinical trial · Observational
Hyperpolarized MRI for GIST on Imatinib
Integrated Precision Imaging for GIST Patients on Imatinib Therapy: Combining Hyperpolarized 13C-MRI, Metabolomics, and Radiomics
- 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)
Conventional imaging methods, such as CT and MRI, are limited in evaluating GIST response to imatinib, as they mainly reflect tumor size and fail to capture early metabolic or molecular changes. This study investigates GISTs from a metabolic perspective by integrating hyperpolarized (HP) 13C-MRI, metabolomics, and radiomics. HP 13C-MRI enables real-time monitoring of metabolic flux in vivo, while NMR-based metabolomics provides systemic insights. In this single-center, prospective observational cohort study, 30 GIST patients receiving imatinib will undergo pre-treatment CT, HP 13C-MRI, metabolomics, and biopsy. Early response will be assessed at one month, with routine evaluation at four months. Patients will be categorized as responders or non-responders, and multi-omics data will be analyzed using machine learning. The study hypothesizes that metabolic changes detected by HP 13C-MRI can predict treatment response, offering reproducible, quantifiable metrics to improve evaluation and patient care.
Conditions
Conditions (2)
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 |
| Imatinib Therapy Response | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized 13C-MRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Responders
- description
- GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.
- interventionNames
- Drug: Hyperpolarized 13C-MRI
- label
- Non-responders
- description
- GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.
- interventionNames
- Drug: Hyperpolarized 13C-MRI
Primary outcomes (1)
- measure
- Metabolic activity in spleen measured as pyruvate-to-lactate conversion rate
- timeFrame
- Data analysis within 7 days after HP 13C-MRI
- description
- The pyruvate-to-lactate conversion calculated by kinetic modeling-based conversion rate of pyruvate-to-lactate (kPL) and model-free metric (signal-to-noise ratio and area-under-curve).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with biopsy proved GIST. 2. Patents will undergo imatinib. 3. Patients have measurable disease on imaging study. 4. Patients more than 18-year-old. Exclusion Criteria: 1. Pregnant or breast-feeding women. 2. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI). 3. Intercurrent illness that will affect the compliance of the patient during the MRI study (e.g., active infection, symptomatic congestive heart failure, uncontrollable angina, arrhythmia, psychiatric disorders, dyspnea, or diarrhea). 4. Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase \>20 × upper limit of normal \[ULN\] or bilirubin \> 10 × ULN). 5. Severe renal impairment (eGFR \<30 ml/min/1.73m2).
References
Publications (0)
Data not yet available