18F-FLUC-CEST PET/MR in Patients With Brain Mets

Phase 3

Recruiting

• Conditions: Brain Metastasis; Immunotherapy, Active; Radiation Therapy

• Registration Number: NCT06159335
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18 years or older<br><br> - Able and willing to provide informed consent<br><br> - Has a brain metastasis diagnosis with at least one single visible contrast enhancing<br> metastatic lesion on brain MRI<br><br> - Received radiation therapy at some point in the last 2 years<br><br> - Is currently being treated with or has been treated with any other concurrent<br> systemic therapy (multi-modal therapy) in the past 6 months, which would include<br> immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or<br> chemotherapy following radiation therapy.<br><br> - Has had at least one previous standard-of-care MRI imaging within the past 60 days<br> for assessment of disease location and extent with increasing enhancement where the<br> question of tumor recurrence versus treatment related change are a clinical<br> question.<br><br> - Be able to lie still for 30-60 minutes during the imaging procedure<br><br> - Willing and able to undergo PET/MRI<br><br> - Patients requiring intravenous (IV) conscious sedation for imaging are not eligible;<br> patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to<br> participate as long as the following criteria are met:<br><br> - The subject has their own prescription for the medication<br><br> - The informed consent process is conducted prior to the self-administration of<br> this medication<br><br> - They come to the research visit with a driver<br><br>Exclusion Criteria:<br><br> - Subject unable or unwilling to provide informed consent<br><br> - Subject is pregnant<br><br> - Subject with contraindication(s) to or inability to undergo a PET or MRI<br><br> - Known allergy to 18F-Fluciclovine or any of its excipients

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amino acid uptake into tumor tissue;Cystolic protein in tumor cells