Clinical trial NCT03964909: Resting-State Functional MRI in Glioma Patients Before and After Surgery
Official title: Resting-State Functional MRI in Glioma Patients Before and After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Mass
Glioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.

SECONDARY OBJECTIVES:

I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.

OUTLINE:

Patients undergo standard of care functional (f)MRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

After completion of study, patients are followed up at 4-6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed brain mass suspected to be gliomas
* English speaker
* Right handed
* Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language
* No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist
* Patients who will undergo neurosurgical resection
* Patients who are on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care
* Patients who will complete pre- and postoperative neuropsychological testing per standard of care
* Pregnant women

Exclusion Criteria:

* Patients with prior radiation or chemotherapy
* Patients cannot give informed consent
* Patients cannot undergo MRI and functional MRI examinations

Primary outcomes:
measure: Detectability of language networks
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Changes in resting-state functional connectivity and neuropsychological outcomes
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ho-Ling A Liu
role: PRINCIPAL_INVESTIGATOR
References: