Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPeritoneal Cancer
- Interventions
- Other: Neuroimaging & Neuropsychological Evaluation
- Registration Number
- NCT01591772
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy controls Neuroimaging & Neuropsychological Evaluation - diagnosed with ovarian that recieved chemo Neuroimaging & Neuropsychological Evaluation -
- Primary Outcome Measures
Name Time Method alterations in regional brain volume 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 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.
- Secondary Outcome Measures
Name Time Method neuropsychological functions 1 year Patients will undergo a brief neuropsychological test battery at MSKCC or at Citigroup Biomedical Imaging Center at WCMC. All subjects will undergo a neuropsychological evaluation including standardized tests of attention and working memory, executive functions, and memory considering that these domains have been shown to be particularly sensitive to cancer treatment-induced cognitive dysfunction.
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States