Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tu… (NCT03604302) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors
United States33 participantsStarted 2018-08-01
Plain-language summary
The purpose of this study is to test the accuracy of using an imaging technique called breath-holding functional magnetic resonance imaging (BH fMRI) in addition to the standard imaging test described above. This study will allow the researchers to find out whether using BH fMRI in combination with the standard approach is the same as, better, or worse than the standard approach used alone.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Health Volunteers
* Volunteers between the ages of 18 and 80 years
* Volunteers must be able to perform the language paradigms on cue while inside the scanner Patients
* Patients between the ages of 18 and 80 years
* Patients must be able to perform the language paradigms on cue while inside the scanner
* Women of child bearing potential must have a negative pregnancy test prior to the study intervention (Serum or Urine)
* Patients diagnosed with primary glial neoplasm, meningioma and metastasis (from prior histology) or must be suspected to have primary glial neoplasm, meningioma and metastasis on imaging (to be confirmed by post-operative histology).
* Patient"s location of the tumor must involve the expected location of Broca"s area (left pars opercularis and/or pars triangularis), or the expected location of the primary motor area (the pre-central gyrus). This determination will be made on the basis of a pre-operative MRI by a fellowship-trained Neuroradiologist
Exclusion Criteria:
Healthy Volunteers
* Volunteers who are unable to comply or complete MRI exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.)
o MSK site only - see Appendix 2
* Volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.)
* Volunteers with a history of neurological disorders, psychiatric disorders or cancer Femal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients that have false negative results