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

This study has been terminated.
(Lack of Accrual)
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01473693
First received: November 10, 2011
Last updated: January 14, 2014
Last verified: January 2014

November 10, 2011
January 14, 2014
November 2011
January 2014   (final data collection date for primary outcome measure)
longitudinal structural changes in the brain [ Time Frame: 1 month following completion of a 6 month course of induction chemotherapy or 7 months following surgery ] [ Designated as safety issue: No ]
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
longitudinal structural changes in the brain [ Time Frame: 1 month following completion of a 6 month course of chemotherapy or 7 months following surgery ] [ Designated as safety issue: No ]
Using MRI in patients diagnosed with non-small cell lung cancer in either the chemotherapy exposed or surgery-only group in dorsolateral prefrontal cortex or bilateral hippocampus
Complete list of historical versions of study NCT01473693 on ClinicalTrials.gov Archive Site
longitudinal structural changes in the brain [ Time Frame: 1 month following completion of a 6 month course of induction chemotherapy ] [ Designated as safety issue: No ]
Using MRI in patients diagnosed with non-small cell lung cancer in the induction chemotherapy exposed group in dorsolateral prefrontal cortex or bilateral hippocampus.
longitudinal structural changes in the brain [ Time Frame: 1 month following completion of a 6 month course of chemotherapy ] [ Designated as safety issue: No ]
Using MRI in patients diagnosed with non-small cell lung cancer in the chemotherapy exposed group in dorsolateral prefrontal cortex or bilateral hippocampus.
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Thoracic Oncology, Radiation Oncology, Surgery or Ambulatory Care clinic lists

Non-small Cell Lung Cancer
  • 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.

  • Other: 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

  • 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.
    Intervention: Other: MRI Screening Form, MRI, Demographic / Medical Data form
  • 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.
    Intervention: Other: MRI Screening Form, MRI. Demographic / Medical Data
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
January 2014
January 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473693
11-145
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: James C Root, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP