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
  Purpose

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.


Condition Intervention
Non-small Cell Lung Cancer
Other: MRI Screening Form, MRI, Demographic / Medical Data form
Other: MRI Screening Form, MRI. Demographic / Medical Data

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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.
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


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473693

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: James C Root, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01473693     History of Changes
Other Study ID Numbers: 11-145
Study First Received: November 10, 2011
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
Lung cancer
MRI
Surgery
induction chemotherapy
11-145

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 10, 2014