Non-small Cell Lung CancerNCT01473693
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
An observational study of Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- MRI Screening Form, MRI, Demographic / Medical Data form and MRI Screening Form, MRI. Demographic / Medical Data
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thoracic Oncology, Radiation Oncology, Surgery or Ambulatory Care clinic lists
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- MRI Screening Form, MRI, Demographic / Medical Data form, MRI Screening Form, MRI. Demographic / Medical Data
- Keywords
- Quality of Life, Lung cancer, MRI, Surgery, induction chemotherapy, 11-145
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Screening Form, MRI, Demographic / Medical Data formOther
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 DataOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MRI Screening Form, MRI. Demographic / Medical Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Using MRI in patients diagnosed with non-small cell lung cancer in the induction chemotherapy exposed group in dorsolateral prefrontal cortex or bilateral hippocampus.
Measured: 1 month following completion of a 6 month course of induction chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Lack of Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Root, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473693
- Sponsor's protocol ID
- 11-145
- Status last verified
- Jan 2014
- First submitted
- 10 Nov 2011
- Last updated
- 16 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01473693
- Acronym / sponsor ID
- 11-145
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Quality of Life, Lung cancer, MRI, Surgery, induction chemotherapy, 11-145
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery-only group | – | Other: MRI Screening Form, MRI, Demographic / Medical Data formThis 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 | – | Other: MRI Screening Form, MRI. Demographic / Medical DataThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic Oncology, Radiation Oncology, Surgery or Ambulatory Care clinic lists
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI Screening Form, MRI, Demographic / Medical Data formMRI 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 | surgery-only group |
| MRI Screening Form, MRI. Demographic / Medical DataMRI 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 | induction chemotherapy group |
Primary outcome
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 secondary outcome
longitudinal structural changes in the brain
Time frame: 1 month following completion of a 6 month course of induction chemotherapy
Results and safety
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Root, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014; AzTrials last refreshed its copy on 1 Nov 2026.