Changes in Brain Structure Related to Systemic Chemotherapy Treatment: A Prospective Study in Individuals Diagnosed With Non-small Cell Lung Cancer Utilizing High-resolution Structural Magnetic Resonance Imaging

Study Overview
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Brief Summary
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The purpose of this study is to learn about the effects of cancer treatment on the brain. Some cancer patients report changes in their memory or thinking after treatment. These changes could be a result of changes in brain structure, such as a change in size or thickness of different parts of the brain. The investigators will look to see if these changes in brain structure happen through the results of magnetic resonance imaging (MRI). The investigators will do this by looking at the brain structure of lung cancer patients who have surgery and chemotherapy versus those who have surgery only.

Official Title
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Changes in Brain Structure Related to Systemic Chemotherapy Treatment: A Prospective Study in Individuals Diagnosed With Non-small Cell Lung Cancer Utilizing High-resolution Structural Magnetic Resonance Imaging

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: MRI Screening Form, MRI, Demographic / Medical Data form
* Other: MRI Screening Form, MRI. Demographic / Medical Data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 80 years old As per self report and/or medical record female patients are either postmenopausal or not able to become pregnant Patients with biopsy proven or suspected non-small cell lung cancer planned to undergo induction chemotherapy and surgery, OR with biopsy proven or suspected non-small cell lung cancer planned to undergo immediate surgical resection No clinical/neurological symptoms suggestive of brain metastases by attending's judgment as documented in the medical record and/or correspondence with the research team In the judgement of the consenting professional, patient is able to understand English, through verbal and written communication Patient is able to undergo MRI scanning (verified with pre-MRI Safety Screening form (Appendix A) used in MSKCC MRI Centers) completed at screening and again prior to having the MRI. Exclusion Criteria: Patients with history of significant neurological diagnoses including stroke, tumor, dementia, epilepsy, or multiple sclerosis as indicated by medical records and/or self report History of head injury with evidence of brain injury or loss of consciousness for > 60 minutes as per EMR or self-report No prior treatment with chemotherapy Participant has dentures, body jewelry or wig that they are unable to remove as per self-report Patient reports that he/she cannot undergo MRI scanning without significant distress or discomfort Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study (i.e., schizophrenia).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery-only group<br>This will be a prospective study to investigate chemotherapy related structural brain changes in individuals undergoing anatomic lung resection for non-small cell carcinoma with and without, induction systemic chemotherapy treatment. | Other: MRI Screening Form, MRI, Demographic / Medical Data form<br>* MRI Screening Form: MRI screening form will be administered twice at baseline and follow up visits. Administration time: 5 minutes. MRI data: at both time points (pre- and post-treatment only) Administration time: 30 minutes. Demographic / Medical Data: Administration time: 5 minutes.<br>|
| induction chemotherapy group<br>This will be a prospective study to investigate chemotherapy related structural brain changes in individuals undergoing anatomic lung resection for non-small cell carcinoma with and without induction systemic chemotherapy treatment. | Other: MRI Screening Form, MRI. Demographic / Medical Data<br>* MRI Screening Form: MRI screening form will be administered twice at baseline and follow up visits Administration time: 5 minutes. MRI data: at both time points (pre- and post-treatment only) Administration time: 30 minutes. Demographic / Medical Data: Administration time: 5 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| longitudinal structural changes in the brain | Using MRI in patients diagnosed with non-small cell lung cancer in either the induction chemotherapy exposed or surgery-only group in dorsolateral prefrontal cortex or bilateral hippocampus | 1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| longitudinal structural changes in the brain | Using MRI in patients diagnosed with non-small cell lung cancer in the induction chemotherapy exposed group in dorsolateral prefrontal cortex or bilateral hippocampus. | 1 month following completion of a 6 month course of induction chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Lung cancer, MRI, Surgery, induction chemotherapy, 11-145