Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT04390906
Eligibility Criteria:
Inclusion Criteria:
* \>18 years old patients with brain tumors including low grade gliomas, meningiomas, acoustic neuromas, pituitary adenomas, craniopharyngiomas, hemangiopericytomas, pineal tumors, and other benign or slow-growing brain tumors
* Pathologic diagnosis will be required for gliomas, but not for other tumor types (though it will be recorded if available)
* Within 3 months prior to registration, patients must have a post gadolinium contrast-enhanced three dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2/FLAIR sequence. To yield acceptable image quality with the smallest possible axial slice thickness, , the imaging protocol should include the standard brain tumor protocol sequences: long DTI, sagittal SPGR, and brainlab sequences, resting functional MRI or their equivalent.
* Patients will need to be planned to receive fractionated radiation therapy or stereotactic radiation therapy, either fractionated or single fraction (enrollment must occur prior to radiation therapy so that baseline neurocognitive evaluation can be done)
* Surgical excision and/or chemotherapy treatment prior to enrollment is allowed
* Concurrent chemotherapy with radiation is allowed
* Antiepileptic drugs use, seizures, steroids, anticholinergic medications will be recorded but patients will not be excluded
* Hydrocephalus will be recorded, but patients will not be excluded
Exclusion Criteria:
* Prior cranial radiation therapy
* Other active malignancy
* Contraindication to MRI imaging such as implanted metal devices or foreign bodies
* Contraindication to gadolinium contrast administration during MR imaging such as allergy or insufficient renal function
* Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months
* Life expectancy \<6 months due to other severe comorbidity
* Due to limitations in our ability to test patients in languages other than English, patients will have to be English-speaking
* Diagnosis of pre-existing dementia (clinically significant as defined by a neurologist or other provider), neurodegenerative, or neuro-inflammatory conditions as made by an appropriate health care professional such as a neurologist
* Inability to participate in neuro-cognitive testing
* Significant aphasia leading to difficulty participating in neuro-cognitive testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04390906
Study Brief:
Protocol Section:
NCT04390906