Hyperpolarized MRI for GIST on Imatinib

NCT07724626 | Not Yet Recruiting DMC FDA Drug

• 2 other identifiers: DNP_GIST114-2314-B-182A-118-MY3
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Imatinib Therapy Response; Gastrointestinal Stromal Tumor (GIST)

Keywords

Gastrointestinal Stromal Tumor (GIST); Imatinib Therapy; Hyperpolarized 13C-MRI; Dynamic Nuclear Polarization (DNP); Radiomics

Outcome Measures

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).

  Data analysis within 7 days after HP 13C-MRI

Study Arms (2)

Responders

GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.

Drug: Hyperpolarized 13C-MRI

Non-responders

GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.

Drug: Hyperpolarized 13C-MRI

Interventions

Hyperpolarized 13C-MRI DRUG

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

Non-responders; Responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patients with biopsy proved GIST.
• Patents will undergo imatinib.
• Patients have measurable disease on imaging study.
• Patients more than 18-year-old.

You may not qualify if:

• 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).
• Severe renal impairment (eGFR \<30 ml/min/1.73m2).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Ying-Chieh Lai, MD

  Chang Gung Memorial Hospital, Link

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Chieh Lai, MD

CONTACT

+88633281200; cappolya@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)