Hyperpolarized MRI for GIST on Imatinib (DNP_GIST)
2026年7月21日 更新者:Chang Gung Memorial Hospital
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Ying-Chieh Lai, MD
- 电话号码:2585 +88633281200
- 邮箱:cappolya@gmail.com
学习地点
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-
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Taoyuan、台湾、333
- Chang Gung Memorial Hospital
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接触:
- Ying-Chieh Lai, MD
- 电话号码:2585 +88633281200
- 邮箱:cappolya@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
Inclusion Criteria:
- Patients with biopsy proved GIST.
- Patents will undergo imatinib.
- Patients have measurable disease on imaging study.
- Patients more than 18-year-old.
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Responders
GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.
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Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
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Non-responders
GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.
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Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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脾脏的代谢活动以丙酮酸到乳酸的转化率来衡量
大体时间:HP 13C-MRI 后 7 天内的数据分析
|
通过基于动力学模型的丙酮酸到乳酸的转化率 (kPL) 和无模型指标(信噪比和曲线下面积)计算出丙酮酸到乳酸的转化率。
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HP 13C-MRI 后 7 天内的数据分析
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ying-Chieh Lai, MD、Chang Gung Memorial Hospital, Link
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年1月1日
初级完成 (估计的)
2028年7月31日
研究完成 (估计的)
2028年10月31日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- DNP_GIST
- 114-2314-B-182A-118-MY3 (其他标识符:National Science and Technology Council (Taiwan))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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