13C-Pyruvate DNP MR Spectroscopy for Detecting Early Treatment Response in Patients With Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- Assessment of early treatment response of lymphoma patients using 13C pyruvate DNP MR spectroscopy
研究概览
简要总结
This study has two stages and the aims are as follows:
Aim 1:
In Stage 1 of this study, the investigators aim to recruit first-time diagnosed lymphoma patients, to understand the changes of metabolites before and after treatment, and to evaluate the ability of hyperpolarized 13C-labeled pyruvate from dynamic nuclear polarization (DNP) magnetic resonance spectroscopy (MRS) for detecting early treatment response in these patients.
The pre-treatment metabolic imaging biomarker levels will be compared to the followings:
- Post-treatment metabolites from 13C-pyruvate DNP MRS after the first week of chemotherapy
- Interval change in tumor size
- ADC values from diffusion weighted imaging (DWI), SUV values from 18F-FDG PET/CT before and after the first week of chemotherapy
- Pre-treatment and interim follow up SUV values from 18F-FDG PET/CT
- Post-treatment outcome and to understand the change of metabolites before and after treatment and if possible, evaluate treatment outcome using the above imaging biomarkers
Aim 2:
In Stage 2 of this study, the investigators aim to recruit lymphoma patients with proven relapse after treatment, to understand the changes of metabolites before and after treatment, to compare the metabolite changes with Stage 1 patients and to evaluate the ability of hyperpolarized 13C-labeled pyruvate from DNP MRS for detecting early treatment response in these patients.
详细描述
Background Information
Metabolites from aberrant metabolic pathways in lymphoma Cells can be detectable through DNP 13C Pyruvate MR Spectroscopy and its potential benefit in lymphoma patients
Lymphoma is a common cause of malignancy. The assessment of tumor response after treatment largely depends on comparison of the pre-treatment and post-treatment changes in tumor size, while more advanced imaging methods, such as metabolic imaging, are taking more important roles in early detection of tumor response. Moreover, early tumor response to treatment were also indicators of future clinical outcome. Measurement of changes in tumor size may be a non-invasive and simple method of evaluating treatment response, but this method lacks sensitivity because some patients may require more than several weeks before evidence of tumor shrinkage can be shown. In addition, tumor treatment may result in a stasis of tumor size, which the differentiation between post-treatment residual tumor from non-viable mass may also be challenging. If the tumor is not responding, a more effective treatment regimen could be initiated; rapidly changing the patient to a more effective drug not only is cost-effective but also can greatly improve morbidity and mortality.
Metabolic imaging of tumor utilizes the metabolic dominance of tumor through the glycolysis process, which is the Warburg effect. Similar to 18F-FDG PET/CT, which glycolysis is upregulated between in malignant tumor as compared to normal tissue; Pyruvate, the intermediate metabolite from glycolysis and the main substrate for our study, can be further metabolized according to the pathways:
(A) Lactate through the lactate dehydrogenate pathway which is the main target for the analysis in our study (B) Bicarbonate (HCO3) through the nicotinamide adenine dinucleotide (NAD) <--> NADH (H for hydrogen) pathway (C) Glutamate and Alanine through the tricarboxylic acid cycle (TCA) cycle
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide signed informed consent
- •Willing to receive 13C-pyruvate DNP MRS and return for post-treatment evaluation for the scheduled follow up imaging about 1 week after initiation of chemotherapy.
- •Willing to receive therapy and follow-up as suggested by the tumor board and combined conference meeting in our institution
- •Presence of enlarged neck lymph nodes and/or spleen to serve as localized target for 3C-pyruvate DNP MRS
- •The exclusion criteria include:
- •Contraindicated to MRI study: such as cardiac pacemaker, cochlear implantation, metallic object within eyeball
- •Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobilit
排除标准
- •Contraindicated to MRI study: such as cardiac pacemaker, cochlear implantation, metallic object within eyeball
- •Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobilit
研究组 & 干预措施
Patients having 13C Pyruvate DNP for lymphoma early treatment response evaluate
In stage 1, we expected to enroll 8 first-time diagnosed lymphoma patients referred from clinicians for 13C-pyruvate DNP MRS. In stage 2, another 8 patients with proven relapse will be referred from clinicians for 13C-pyruvate DNP MRS. We will collect related clinical information, patient follow up information, including treatment outcome, and imaging parameters from MRI and PET/CT.
干预措施: hyperpolarized 13C-labeled pyruvate from dynamic nuclear polarization (DNP) magnetic resonance spectroscopy (Drug)
结局指标
主要结局
Assessment of early treatment response of lymphoma patients using 13C pyruvate DNP MR spectroscopy
时间窗: 2 years
The changes in metabolic tumor sizes
次要结局
未报告次要终点