Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- alterations in regional brain volume
研究概览
简要总结
The purpose of this study is to learn about possible changes in brain anatomy and function, and in thinking abilities, such as memory skills, in patients with ovarian cancer who receive treatment with chemotherapy. Cancer patients treated with chemotherapy may experience changes in thinking abilities, and these may interfere with quality of life. Most of the research to date has involved patients with breast cancer, and there are no studies in women with ovarian cancer looking at at treatment-related changes in brain anatomy and function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •diagnosed with stage I-IV ovarian, peritoneal or fallopian tube cancer
- •completed first-line taxane and platinum-based chemotherapy 1-4 months prior to being enrolled in the study (can be on bevacizumab maintenance)
- •in remission of their disease at the time of enrollment between 21 and 70 years of age
- •fluent in English
- •in the judgment of the consenting professional, have capacity to give consent
- •Healthy Control Inclusion Criteria:
- •no diagnosis of cancer except basal cell carcinoma
- •between 21 and 70 years of age
- •fluent in English
- •has a mini-mental state exam (MMSE) score of 26 or higher
- •in the judgment of the consenting professional, have capacity to give consent
排除标准
- •active or recurrent disease, or diagnosis of another cancer (except basal cell carcinoma) as per medical records at the time of enrollment
- •exposure to chemotherapy or radiation therapy for any medical condition unrelated to ovarian cancer
- •on hormonal therapy at the time of enrollment
- •neurological disorder or moderate to severe head trauma (loss of consciousness > 60 min)
- •neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
- •self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
- •unable to complete cognitive tests
- •with standard contraindications to MRI examinations
- •Healthy Control Exclusion Criteria:
- •exposure to chemotherapy or radiation therapy for any medical condition
- •on hormone replacement therapy at the time of enrollment
- •neurological disorder or moderate to severe head trauma (loss of consciousness > 60 min)
- •neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
结局指标
主要结局
alterations in regional brain volume
时间窗: 1 year
will undergo structural MRI scans on a Siemens 3T Magnetom Tim Trio research scanner located at the Citigroup Biomedical Imaging Center at Weill Cornell Medical Center (WCMC), which is adjacent to the MSKCC campus. Three to five T1 weighted sagittal slices are collected to localize the anterior and posterior commissures. Functional imaging: Blood Oxygenation Level-Dependent (BOLD) contrast imaging, which reflects changes in venous deoxyhemoglobin associated with neuronal activity, will be used.
dorsolateral prefrontal cortex
时间窗: 1 year
will undergo functional MRI scans on a Siemens 3T Magnetom Tim Trio research scanner located at the Citigroup Biomedical Imaging Center at Weill Cornell Medical Center (WCMC), which is adjacent to the MSKCC campus.Three to five T1 weighted sagittal slices are collected to localize the anterior and posterior commissures. Functional imaging: Blood Oxygenation Level-Dependent (BOLD) contrast imaging, which reflects changes in venous deoxyhemoglobin associated with neuronal activity, will be used.
次要结局
- neuropsychological functions(1 year)