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Neurococognitive and Functioal Assessment of Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT01861405
Recruitment Status : Unknown
Verified December 2014 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:

The investigators seek to perform an observational study in patients with brain metastases that are to undergo whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) treatment in order to quantify any baseline neurocognitive changes which may result from intracranial disease burden, from radiation treatment (WBRT or SRS), or both. To do so, the investigators will compare matched control subjects to patients at time points obtained before and after radiation treatment with either SRS or WBRT. Pre-treatment evaluation will include neurocognitive testing and an assessment of fMRI task-related activation patterns and resting state brain activity. Four and twelve month post-treatment neuropsychological evaluations will be performed and pre- and 4-month post-treatment fMRI scans will be obtained in order to evaluate changes in neurocognitive functioning with a focus on short-term memory and executive function domains. A brief quality of life assessment will also be completed at each study time point. In order to plan treatment strategies in the future it is important to accurately document the effects of intracranial disease burden as well as radiation treatment on neurocognitive functioning, validate fMRI activation tasks for short term memory and executive functioning, and quantify the activation volumes that would potentially be spared in future "cognitive sparing" protocols.

The investigators hypothesize first that the amount and location of intracranial disease burden will represent pre-treatment variables that affect NCF. The compromised NCF will be visualized in both the resting state and task-oriented neurocognitive exercise. The investigators anticipate that any perturbation in resting state caused by intracranial disease burden should be reflected in patients when compared to matched controls.

The investigators hypothesize additionally that cancer patients with brain metastases undergoing radiation treatments will have improved intracranial disease control at the expense of executive and memory function with differences between patients that undergo stereotactic radiosurgery or whole brain radiation alone.


Condition or disease Intervention/treatment
Cerebral Metastases Patients Behavioral: neuropsychological testing and quality of life assessments Radiation: Standard of Care WBRT or SRS Device: Functional magnetic resonance imaging

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurocognitive and fMRI Activation Changes Observed at Baseline and After Whole Brain Radiation vs. Radiosurgery for Patients With Cerebral Metastases: a Prospective Case-control Analysis.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015

Group/Cohort Intervention/treatment
Cerebral metastases subjects
Prior to each subject's radiation treatment (either whole brain radiation therapy or stereotactic radiosurgery), he/she will have fMRI scanning and neuropsychological testing and conduct a quality of life assessment. Each subject will then have standard of care WBRT or SRS treatment. Following WBRT or SRS treatment, subjects will have 4 month follow up fMRI scanning, and have neuropsychological testing and a quality of life assessment 4 months and 12 months post treatment.
Behavioral: neuropsychological testing and quality of life assessments
Radiation: Standard of Care WBRT or SRS
Device: Functional magnetic resonance imaging
Healthy participants
Healthy control subjects will be matched by age, gender, education, ect. to cerebral metastases subjects. Each will have fMRI scannings (3 total), neuropsychological testings (3 total), and quality of life assessments (3 total) at the same time points as their matched cerebral metastases subject.
Behavioral: neuropsychological testing and quality of life assessments
Device: Functional magnetic resonance imaging



Primary Outcome Measures :
  1. To establish, through neurocognitive testing and fMRI, a correlation between baseline resting state functional brain connectivity, fMRI task related activation patterns and neurocognitive functioning (NCF) in patients with brain metastases. [ Time Frame: Continuous throughout 24 month study participation ]

Secondary Outcome Measures :
  1. To establish from normal control data a reliable change index (RCI) in order to establish the significance and magnitude of any baseline deviations in neurocognitive functioning (NCF) in patients with brain metastases. [ Time Frame: Continuous throughout 24 month study participation ]
  2. To establish through paired comparisons any significant changes from baseline in NCF and fMRI data after radiation treatmentin patients with brain metastases, adjusted respectively from a reliable change index and statistical parameters. [ Time Frame: Continuous throughout 24 month study participation. ]
  3. To utilize the data from Aims 1-3 to design a prospective randomized comparison of patient outcomes after SRS alone vs. WBRT, stratified by good and poor baseline NCF groups. [ Time Frame: Continuous throughout 24 month study participation ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain metastases will be referred through the department of Neurosurgery and Radiation-oncology at Thomas Jefferson University Hospital. Healthy subjects will recruited through postings distributed around the hospital and university bulletin boards and through an advertisement in a local newspaper.
Criteria

Inclusion Criteria:

  • Patients with a cumulative intracranial disease burden of up to but not exceeding 8cc.
  • Patients with newly diagnosed brain metastases are undergoing WBRT or SRS as previously determined by their oncologist and or radiation oncologist.
  • Right or left hand dominance.
  • Karnofsky performance status (KPS) equal to or greater than 70.
  • 70 years old or younger.
  • All non-hematopoietic histologies except melanoma and renal cell carcinoma.
  • Brainstem lesions are acceptable.
  • Normal renal function to tolerate a contrast enhanced MRI scan.
  • Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  • Age less than 18 years old.
  • KPS <70.
  • Pregnant female.
  • Active systemic disease.
  • Age greater than 70 years old.
  • Patients with leptomeningeal metastases.
  • Contraindication for MRI such as implanted metal devices, foreign bodies or severe claustrophobia or axial back pain precluding a prolonged MRI study.
  • Prior radiation therapy to the brain.
  • Poor renal function rendering contrast enhanced MRI un-obtainable.
  • Histological diagnosis of small cell lung cancer.
  • Craniotomy or other major surgery within 2 weeks of start of either SRS or WBRT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861405


Contacts
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Contact: Meghan Wakefield, RN 215-503-9110 meghan.wakefield@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Yaron Moshel, MD, PhD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Yaron Moshel, MD, PhD Thomas Jefferson University

Publications:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01861405     History of Changes
Other Study ID Numbers: 13D.02
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes