Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Intervention / Treatment
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* Other: Neuroimaging & Neuropsychological Evaluation
* Other: Neuroimaging & Neuropsychological Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diagnosed with ovarian that recieved chemo<br> | Other: Neuroimaging & Neuropsychological Evaluation<br>* Will undergo structural and 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. Patients do not undergo routine clinical brain MRIs as part of their assessment and treatment, and the brain MRI scans to be performed in this study are for research purposes only. The MRI scan takes approximately 60 minutes to complete, and about 15 minutes will be required for instructions prior to initiating the study. The MRI studies will be reviewed by a neuroradiologist (Dr. Karimi) to rule out gross structural CNS abnormalities; in case any abnormalities considered to require clinical follow-up are detected, the subject will be contacted and referred for follow-up with their treating physician. Patients will undergo a brief neuropsychological test battery at MSKCC or at Citigroup Biomedical Imaging Center at WCMC<br>|
| healthy controls<br> | Other: Neuroimaging & Neuropsychological Evaluation<br>* Will undergo structural and 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. Patients do not undergo routine clinical brain MRIs as part of their assessment and treatment, and the brain MRI scans to be performed in this study are for research purposes only. The MRI scan takes approximately 60 minutes to complete, and about 15 minutes will be required for instructions prior to initiating the study. The MRI studies will be reviewed by a neuroradiologist (Dr. Karimi) to rule out gross structural CNS abnormalities; in case any abnormalities considered to require clinical follow-up are detected, the subject will be contacted and referred for follow-up with their treating physician. Patients will undergo a brief neuropsychological test battery at MSKCC or at Citigroup Biomedical Imaging Center at WCMC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alterations in regional brain volume | 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. | 1 year | 
| dorsolateral prefrontal cortex | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological functions | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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12-075, structural MRI, FALLOPIAN TUBE, OVARY, PERITONEUM, Quality of Life, functional MRI, neuropsychological assessment