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Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01591772
Enrollment
36
Registered
2012-05-04
Start date
2012-04-24
Completion date
2022-05-25
Last updated
2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Keywords

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

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.

Interventions

OTHERNeuroimaging & 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

Sponsors

Weill Medical College of Cornell University
CollaboratorOTHER
Rutgers University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
alterations in regional brain volume1 yearwill 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 cortex1 yearwill 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

MeasureTime frameDescription
neuropsychological functions1 yearPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026