Clinical trial NCT01473693: 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
Official title: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-small Cell Lung Cancer
Keywords: Quality of Life
Lung cancer
MRI
Surgery
induction chemotherapy
11-145
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thoracic Oncology, Radiation Oncology, Surgery or Ambulatory Care clinic lists

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.


Eligibility criteria: 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).

Primary outcomes:
measure: longitudinal structural changes in the brain
timeFrame: 1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgery
Secondary outcomes:
measure: longitudinal structural changes in the brain
timeFrame: 1 month following completion of a 6 month course of induction chemotherapy
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James C Root, PhD
role: PRINCIPAL_INVESTIGATOR
References: