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:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05904704
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18 years of age or older) with a known or suspected intracranial tumor
* Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf
* Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired
* Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) magnetic resonance (MR) imaging
* Karnofsky performance score \> 60 or Eastern Cooperative Oncology Group (ECOG) \< 3 as assessed by referring clinician
* Planning to undergo or previously received therapeutic intervention for the intracranial tumor
Exclusion Criteria:
* Pregnant or breastfeeding
* Contraindication to supplemental oxygen administration, MRI, or intravenous gadolinium based contrast agents.
* Claustrophobia
* Weight greater than modality maximum capacity
* Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \& Science University (OHSU) Department of Radiology guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
* Sickle cell disease
* Unsure of pregnancy status as assessed by Department of Radiology and Advanced Imaging Research Center (AIRC) guidelines
* Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation or chronic respiratory insufficiency (end-stage chronic obstructive pulmonary disease \[COPD\], obstructive sleep apnea \[OSA\] on continuous positive airway pressure \[CPAP\]/biphasic positive airway pressure \[Bi-PAP\], etc)
* Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study
* Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care)
* Poor peripheral intravenous access evaluated by patient history
* Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the study or limit compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05904704
Study Brief:
Protocol Section:
NCT05904704