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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06101069
Eligibility Criteria:
Inclusion Criteria for Healthy Participants:
* No history of cerebrovascular disease.
* No cognitive impairments.
* Able to provide informed consent.
Inclusion Criteria for Participants with Brain Tumors:
* Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR
* a. PET identified with developed recurrent tumor or radiation necrosis. OR
* b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.
* ECOG performance status 0-2.
* Life expectancy \> 6 months.
* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
Inclusion Criteria for Participants with Brain Metastases or Primary Gliomas:
* Radiology identified with developed primary gliomas tumor or brain metastases, OR
* a. PET identified with developed gliomas tumor or brain metastases, OR
* b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board
* Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.
* Age: 21 years and over
* ECOG performance status 0-2
* Life expectancy \> 6 months.
* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
Exclusion Criteria:
* Pregnant women OR lactating women
* Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
* Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
* Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.
* Known history of severe claustrophobia.
* Participants unable to lay still in the scanner for 30 minutes at a time.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT06101069
Study Brief:
Protocol Section:
NCT06101069