Neurococognitive and Functioal Assessment of Patients With Brain Metastases

Status unconfirmed

Conditions studied: Cerebral Metastases Patients

In brief

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.

Key facts

Study ID: NCT01861405
Run by: Thomas Jefferson University
People needed: 60
Starts: 2013-03-01
Last updated by the study team: 2014-12-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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