Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

NCT01591772 | Completed

• 1 other identifier: 12-075
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer

Keywords

FALLOPIAN TUBE; OVARY; PERITONEUM; Quality of Life; structural MRI; functional MRI; neuropsychological assessment; 12-075

Outcome Measures

Primary Outcomes (2)

• alterations in regional brain volume

  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.

  1 year

• dorsolateral prefrontal cortex

  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.

  1 year

Secondary Outcomes (1)

• neuropsychological functions

  1 year

Study Arms (2)

diagnosed with ovarian that recieved chemo

Other: Neuroimaging & Neuropsychological Evaluation

healthy controls

Other: Neuroimaging & Neuropsychological Evaluation

Interventions

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

diagnosed with ovarian that recieved chemo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator
• Rutgers University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Denise Correa, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 4, 2012
• Study Start: April 24, 2012
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

US (1)