Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

This study is ongoing, but not recruiting participants.
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: August 12, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591772

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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: August 12, 2014
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:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014