A Study of Metabolic Agents Following Brain Radiation

CNS Malignancy Clinical Trial

Official title:

Pilot Imaging Study for CNS Metabolism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06150547
• Other study ID #: 22-009871
• Status: Enrolling by invitation
• Start date: November 14, 2023
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Malignancy

Intervention

Diagnostic Test:
• F-DOPA Positron Emission Tomography
Imaging using a F-DOPA radioactive tracer to look at the head.
• Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects in whom glutamate metabolite is detected and measurable.	Number of subjects in whom glutamate metabolite is detected and measurable via CEST MRI in tumor, brain, and/or the ventricular space.	Baseline
Primary	Number of subjects in whom n-acetylaspartate (NAA) metabolite is detected and measurable.	Number of subjects in whom n-acetylaspartate (NAA) metabolite is detected and measurable via CEST MRI in tumor, brain, and/or the ventricular space.	Baseline
Secondary	Time required to perform the CEST MRI study and measure metabolites of interest	Total time expressed in minutes required to perform the CEST MRI study and measure metabolites of interest.	Duration of CEST MRI scan, approximately one to two hours.

External Links

•   Mayo Clinic Clinical Trials