A Study of Metabolic Agents Following Brain Radiation

Trial Title: A Study of Metabolic Agents Following Brain Radiation

NCT ID: NCT06150547

Condition: CNS Malignancy

Conditions: Official terms:
Central Nervous System Neoplasms
Dihydroxyphenylalanine

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: F-DOPA Positron Emission Tomography
Description: Imaging using a F-DOPA radioactive tracer to look at the head.
Arm group label: Central Nervous System Malignant Tumor

Other name: F-DOPA-PET scan

Intervention type: Diagnostic Test
Intervention name: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
Description: A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.
Arm group label: Central Nervous System Malignant Tumor

Other name: CEST MRI

Summary: This research is being done to determine if CEST Magnetic Resonance Imaging and F-dopa PET are feasible techniques to detect metabolic differences between tumor and brain.

Criteria for eligibility:

Study pop:
Subjects identified as having a central nervous system malignant tumor undergoing routine care in the neuro-oncology practice at Mayo Clinic Rochester.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection. - Provide written informed consent for the current study. - Willing to undergo at least one MRI (at most two) with proton and/or phosphorus magnetic resonance spectroscopy analysis. Exclusion Criteria: - Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped. - Cardiac pacemaker or artificial heart valve - Metal plate, pin, or other metallic implant - Intrauterine device, such as Copper-7 IUD - Insulin or other drug pump - Non-titanium aneurysm clips - Previous gunshot wound - Cochlear implant or other hearing device - Employment history as a metalworker (had metal in eye) - Permanent (tattoo) eye-liner - For 18F-DOPA-PET specifically: Concurrent use of anti-dopaminergic medications or dopamine agonists

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic

Address:
City: Rochester
Zip: 55906
Country: United States

Start date: November 14, 2023

Completion date: December 2028

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06150547
https://www.mayo.edu/research/clinical-trials