Hyperpolarized MRI for GIST on Imatinib

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with biopsy proved GIST.

Patents will undergo imatinib.

Patients have measurable disease on imaging study.

Patients more than 18-year-old.

Disqualifiers

Pregnant or breast-feeding women.

Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).

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).

Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase >20 × upper limit of normal [ULN] or bilirubin > 10 × ULN).

Trial population

The study population consists of 30 patients with gastrointestinal stromal tumors (GIST) undergoing imatinib therapy at a single center. Eligible participants are adults diagnosed with GIST who receive standard-of-care imatinib treatment and undergo imaging and metabolic assessments.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Hyperpolarized 13C-MRI

    Drug

    Metabolic MRI using IV injection of hyperpolarized \[1-13C\]pyruvate.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Responders1 intervention
Group B: Non-responders1 intervention

Trial outcomes

Primary outcomes

1

Metabolic activity in spleen measured as pyruvate-to-lactate conversion rate

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).

Time frame
Data analysis within 7 days after HP 13C-MRI

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

Ministry of Science and Technology, Taiwan

Collaborator

This trial is not recruiting at the moment. You can still explore other options: