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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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01473693
Enrollment
1
Registered
2011-11-17
Start date
2011-11-30
Completion date
2014-01-31
Last updated
2014-01-16

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

Conditions

Non-small Cell Lung Cancer

Keywords

Quality of Life, Lung cancer, MRI, Surgery, induction chemotherapy, 11-145

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.

Interventions

OTHERMRI Screening Form, MRI, Demographic / Medical Data form

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.

OTHERMRI Screening Form, MRI. Demographic / Medical Data

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
longitudinal structural changes in the brain1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgeryUsing 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

MeasureTime frameDescription
longitudinal structural changes in the brain1 month following completion of a 6 month course of induction chemotherapyUsing MRI in patients diagnosed with non-small cell lung cancer in the induction chemotherapy exposed group in dorsolateral prefrontal cortex or bilateral hippocampus.

Countries

United States

Outcome results

None listed

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