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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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

longitudinal structural changes in the brain

Outcome Description:

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

Outcome Time Frame:

1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgery

Safety Issue:

No

Principal Investigator

James C Root, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-145

NCT ID:

NCT01473693

Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Quality of Life
  • Lung cancer
  • MRI
  • Surgery
  • induction chemotherapy
  • 11-145
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021