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Completed

NCT Number: NCT01591772

Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuroimaging & Neuropsychological Evaluation

Other

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

Primary outcomes

  1. alterations in regional brain volume

    Time frame: 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.

  2. dorsolateral prefrontal cortex

    Time frame: 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 outcomes

  1. neuropsychological functions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Rutgers University
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
May 4, 2012
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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