Clinical Trials List
Protocol Number202401986A0
Not yet recruiting
2026-07-01 - 2028-07-31
Phase II
Not yet recruiting1
Integrating Precision Imaging for Gastrointestinal Stromal Tumor Patients Treated with Gleevec: A Combined Approach Using Hyperpolarized Carbon-13 MRI, Metabolomics, and Radiomics
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Trial Applicant
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Sponsor
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2026/09/30
Investigators and Locations
Principal Investigator
賴盈傑
Co-Principal Investigator
- Gigin Lin Division of Radiology
- Tai-Sen Yeh Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Gastrointestinal stromal tumor
Objectives
Hyperpolarized carbon-13 magnetic resonance imaging (HP 13C-MRI) is used to predict, at an early stage, the therapeutic response of gastrointestinal stromal tumor (GIST) patients to Gleevec treatment. Furthermore, the extent of metabolic changes can be correlated with the degree of tumor regression in GIST, thereby providing an objective and accurate prognostic classification. By combining HP 13C-MRI with metabolomics, a deeper understanding of GIST pathophysiology from a metabolic perspective is gained, facilitating the development of innovative therapies.
Test Drug
Hyperpolarized [1-13C]Pyruvate
Active Ingredient
13C PYRUVIC ACID
Dosage Form
Intravenous infusion fluid
Dosage
200-280 mM
Endpoints
To investigate whether metabolic changes can predict treatment response in patients with gastrointestinal stromal tumors (GIST) treated with Gleevec.
Inclution Criteria
1. Histologically confirmed advanced gastrointestinal stromal tumor (GIST) with positive CD117 (c-KIT) expression.
2. Unresectable or metastatic disease, with at least one measurable lesion (longest diameter ≥ 10 mm) per RECIST v1.1 criteria.
3. No prior systemic therapy (no prior treatment with imatinib or other TKIs).
4. Scheduled to receive or currently receiving first-line imatinib (400 mg QD) as standard therapy.
5. Age 18 years or older.
2. Unresectable or metastatic disease, with at least one measurable lesion (longest diameter ≥ 10 mm) per RECIST v1.1 criteria.
3. No prior systemic therapy (no prior treatment with imatinib or other TKIs).
4. Scheduled to receive or currently receiving first-line imatinib (400 mg QD) as standard therapy.
5. Age 18 years or older.
Exclusion Criteria
1. Pregnant or breastfeeding women.
2. Contraindications preventing MRI examination (e.g., claustrophobia, or the presence of MRI-incompatible devices or implants that cannot be removed).
3. Comorbid conditions that might affect patient compliance during the MRI examination (e.g., active infection, symptomatic congestive heart failure, uncontrolled angina, cardiac arrhythmia, psychiatric disorders, dyspnea, or diarrhea).
4. Severe hepatic impairment (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase >20 times the upper limit of normal, or bilirubin >10 times the upper limit of normal).
5. Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73m²).
6. Known hypersensitivity to the excipients of [1-13C]pyruvate.
2. Contraindications preventing MRI examination (e.g., claustrophobia, or the presence of MRI-incompatible devices or implants that cannot be removed).
3. Comorbid conditions that might affect patient compliance during the MRI examination (e.g., active infection, symptomatic congestive heart failure, uncontrolled angina, cardiac arrhythmia, psychiatric disorders, dyspnea, or diarrhea).
4. Severe hepatic impairment (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase >20 times the upper limit of normal, or bilirubin >10 times the upper limit of normal).
5. Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 ml/min/1.73m²).
6. Known hypersensitivity to the excipients of [1-13C]pyruvate.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
