Hyperpolarized MRI for GIST on Imatinib (DNP_GIST)

Integrated Precision Imaging for GIST Patients on Imatinib Therapy: Combining Hyperpolarized 13C-MRI, Metabolomics, and Radiomics

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Stromal Tumor (GIST); Imatinib Therapy Response
• Intervention / Treatment: Drug: Hyperpolarized 13C-MRI

Detailed Description

Conventional imaging techniques, such as CT and MRI, have limitations in assessing GIST response to imatinib. They primarily focus on tumor size, which may not reflect early therapeutic effects, as GISTs can show necrosis or cystic changes that don't correlate with viable tumor tissue reduction. These methods also fail to capture metabolic and molecular alterations within the tumor. As a result, relying solely on size changes can lead to inaccurate or delayed treatment response evaluations, underscoring the need for more advanced imaging techniques. This project is novel because it aims to investigate GISTs undergoing imatinib treatment from a metabolic perspective by integrating hyperpolarized (HP) 13C MRI, metabolomics, and radiomics. HP 13C-MRI is a cutting-edge, non-invasive, real-time dynamic imaging technique used to monitor metabolic flux in vivo. Dynamic nuclear polarization (DNP) enhances the signal of 13C-labeled probes by up to 50,000 times. With DNP, [1-13C]pyruvate can be utilized to study various metabolic pathways, including its conversion to lactate (anaerobic glycolysis), alanine (transamination), and bicarbonate (an indirect marker for the TCA cycle). In our preliminary GIST cell models, significant changes in pyruvate metabolism were observed following imatinib treatment depending on their imatinib resistance. Additionally, NMR-based metabolomics analysis of tumor tissue and blood samples will provide a comprehensive view of systemic metabolic changes. These metabolic alterations will then be linked to MRI radiomics features for a more holistic understanding of treatment response. In this single-center, cross-sectional study, a prospective trial integrates advanced MRI techniques to address clinical challenges and improve patient care in GIST treatment. This 3-year project follows a non-randomized, two-group observational cohort design with 30 GIST patients undergoing imatinib therapy at Chang Gung Memorial Hospital at Linkou (CGMH). Pre-treatment assessments include standard-of-care CT, HP 13C-MRI, 1H-NMR metabolomics, and biopsy of the tumor tissue. HP 13C-MRI will be used to assess metabolic activity in the tumors, while 1H-NMR metabolomics will provide additional insights into systemic metabolic changes. Early response assessment one month after starting imatinib will involve HP 13C-MRI and metabolomics analysis, followed by routine response evaluation at four months using standard CT. Patients will be categorized into responders and non-responders based on treatment efficacy, and data from HP 13C-MRI, metabolomics, and radiomics will be analyzed. Machine learning techniques will integrate multi-omics data for more precise response prediction. We hypothesize that metabolic changes detected through HP 13C-MRI can predict GIST response to imatinib therapy. The extent of metabolic alterations will be correlated with tumor response, providing a new way to evaluate treatment effectiveness. By combining metabolic data with radiomic tissue characteristics, we aim to track dynamic changes in GIST metabolism with reproducible, quantifiable metrics. Ultimately, the integration of HP 13C-MRI and metabolomics will offer a deeper understanding of GIST pathophysiology from a metabolic perspective and could lead to new therapeutic strategies.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Ying-Chieh Lai, MD; Phone Number: 2585 +88633281200; Email: cappolya@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital
    • Contact: Ying-Chieh Lai, MD; Phone Number: 2585 +88633281200; Email: cappolya@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responders; GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.	Drug: Hyperpolarized 13C-MRI; Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
Non-responders; GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.	Drug: Hyperpolarized 13C-MRI; Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Ying-Chieh Lai, MD, Chang Gung Memorial Hospital, Link

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Radiomics; Gastrointestinal Stromal Tumor (GIST); Hyperpolarized 13C-MRI; Imatinib Therapy; Dynamic Nuclear Polarization (DNP)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: DNP_GIST; 114-2314-B-182A-118-MY3 (Other Identifier: National Science and Technology Council (Taiwan))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No