Study Stopped
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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
1 other identifier
observational
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 10, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 16, 2014
January 1, 2014
2.2 years
November 10, 2011
January 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
longitudinal structural changes in the brain
1 month following completion of a 6 month course of induction chemotherapy
Study Arms (2)
surgery-only group
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
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.
Interventions
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 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
Eligibility Criteria
Thoracic Oncology, Radiation Oncology, Surgery or Ambulatory Care clinic lists
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James C Root, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2011
First Posted
November 17, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 16, 2014
Record last verified: 2014-01