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

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: MRI Screening Form, MRI, Demographic / Medical Data form; Other: MRI Screening Form, MRI. Demographic / Medical Data

• Registration Number: NCT01473693
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery-only group	MRI Screening Form, MRI, Demographic / Medical Data form	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.
induction chemotherapy group	MRI Screening Form, MRI. Demographic / Medical Data	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.

Primary Outcome Measures

Name	Time	Method
longitudinal structural changes in the brain	1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States