Overview

This trial is active, not recruiting.

Conditions fallopian tube cancer, ovarian cancer, peritoneal cancer
Treatments neuroimaging & neuropsychological evaluation
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Weill Medical College of Cornell University
Start date April 2012
End date April 2017
Trial size 36 participants
Trial identifier NCT01591772, 12-075

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Arm
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
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

Primary Outcomes

Measure
alterations in regional brain volume
time frame: 1 year
dorsolateral prefrontal cortex
time frame: 1 year

Secondary Outcomes

Measure
neuropsychological functions
time frame: 1 year

Eligibility Criteria

Female participants from 21 years up to 70 years old.

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.

Additional Information

Official title Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer
Principal investigator Denise Correa, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.