Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer |
Other: Neuroimaging & Neuropsychological Evaluation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer |
- alterations in regional brain volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- neuropsychological functions [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| diagnosed with ovarian that recieved chemo |
Other: Neuroimaging & Neuropsychological Evaluation
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
|
| healthy controls |
Other: Neuroimaging & Neuropsychological Evaluation
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
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients will be identified and recruited by physicians in the Gynecologic Medical Oncology Clinic at MSKCC.
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.
Contacts and Locations| Contact: Denise Correa, PhD | 212-639-2339 | |
| Contact: Martee Hensley, MD, MSc | 646-888-4222 |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Denise Correa, PhD 212-639-2339 | |
| Contact: Martee Hensley, MD, MSc 646-888-4222 | |
| Principal Investigator: Denise Correa, PhD | |
| Weill Cornell Medical Center | Not yet recruiting |
| New York, New York, United States | |
| Contact: Norman Relkin, MD, PhD 212-746-2441 | |
| Principal Investigator: | Denise Correa, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01591772 History of Changes |
| Other Study ID Numbers: | 12-075 |
| Study First Received: | April 30, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
FALLOPIAN TUBE OVARY PERITONEUM Quality of Life |
structural MRI functional MRI neuropsychological assessment 12-075 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms |
Abdominal Neoplasms Digestive System Neoplasms Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 19, 2013