Evaluating the Role of Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
研究概览
简要总结
This pilot early phase I trial studies how well diffusion tensor imaging works in predicting development of chemotherapy induced peripheral neuropathy in patients with breast cancer. Diffusion tensor imaging may help to get better pictures of the nerves of feet and lower legs before and after chemotherapy treatment and may help to predict the risk of developing peripheral neuropathy.
详细描述
PRIMARY OBJECTIVES:
I. To assess the changes in the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values of the lower extremity nerves by diffusion tensor imaging (DTI) before initiation and after completion of taxane chemotherapy in patients with breast cancer.
SECONDARY OBJECTIVES:
I. Establish normal and abnormal FA and ADC values of the lower extremity nerves.
II. Evaluate relationship of DTI findings of chemotherapy induced peripheral neuropathy (CIPN) with self-reported Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity questionnaire (FACT-GOT-NTX) questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- •Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- •Have a histologically-confirmed diagnosis of breast cancer
- •Need to be treated with taxane containing chemotherapy as determined by their treating physician
- •Be able to undergo magnetic resonance (MR) imaging
- •Be willing and able to comply with scheduled visits, treatment plan, and MR imaging
排除标准
- •Have non-MRI compatible metallic objects on/in body
- •Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
- •Are unable to lay still in the MR scanner for length of examination
- •Have severe claustrophobia
- •Have pre-existing peripheral neuropathy from other medical conditions or due to cancer
- •Have diagnosis of diabetes
- •Pregnant patients
- •Prior exposure to neurotoxic chemotherapy
结局指标
主要结局
Changes in apparent diffusion coefficient (ADC) of the lower extremity nerves by diffusion tensor imaging (DTI)
时间窗: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
The quantitative DTI parameters measured before the initiation of and after completion of chemotherapy will be compared and used to calculate the degree of change. Descriptive statistics (with confidence interval \[CI\]) will be used for the current sample size.
Changes in quantitative fractional anisotropy (FA) of the lower extremity nerves by diffusion tensor imaging (DTI)
时间窗: Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy)
The quantitative DTI parameters measured before the initiation of and after completion of chemotherapy will be compared and used to calculate the degree of change. Descriptive statistics (with confidence interval \[CI\]) will be used for the current sample size.
次要结局
- Inter-reader variability and reproducibility in measuring fractional anisotropy (FA) by diffusion tensor imaging (DTI)(Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy))
- Inter-reader variability and reproducibility in measuring apparent diffusion coefficient (ADC) by diffusion tensor imaging (DTI)(Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy))
- Normal fractional anisotropy (FA) values of lower extremity nerves(Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy))
- Normal apparent diffusion coefficient (ADC) values of lower extremity nerves(Pre-Treatment (0-30 days prior to receiving first chemotherapy) and Post-Treatment (0-30 days after last day of chemotherapy))
- Peripheral neuropathy severity questionnaires(Pre-Treatment (0-30 days prior to receiving first chemotherapy) and on last day of chemotherapy)