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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01473693
• Other study ID #: 11-145
• Status: Terminated
• Phase: N/A
• First received: November 10, 2011
• Last updated: January 14, 2014
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• MRI 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.
• MRI 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

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center