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

January 14, 2014 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
longitudinal structural changes in the brain
Time Frame: 1 month following completion of a 6 month course of induction chemotherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: James C Root, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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