Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01591772
First received: April 30, 2012
Last updated: April 10, 2014
Last verified: April 2014

April 30, 2012
April 10, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01591772 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
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Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
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.

Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

Patients will be identified and recruited by physicians in the Gynecologic Medical Oncology Clinic at MSKCC.

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
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
  • diagnosed with ovarian that recieved chemo
    Intervention: Other: Neuroimaging & Neuropsychological Evaluation
  • healthy controls
    Intervention: Other: Neuroimaging & Neuropsychological Evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Female
21 Years to 70 Years
Yes
Contact: Denise Correa, PhD 212-639-2339
Contact: Martee Hensley, MD, MSc 646-888-4222
United States
 
NCT01591772
12-075
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Principal Investigator: Denise Correa, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP