Protocol No.UW23061
Principal InvestigatorVeronesi, Michael
PhaseIII
Age GroupAdult
ClinicalTrials.GovNCT06159335 (Click to jump to clinicaltrials.gov)
Management Group(s) Radiology

Title
Use of Amide-Cest MRI and 18F-Fluciclovine Pet for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy

Description
The purpose of this research is to utilize new imaging methods to aid in assessing whether imaging shows presence of tumor. Developing imaging technologies is critical for more accurately identifying location and amount of tumor, which will then lead to improvements in future cancer therapy.

This study aims to evaluate imaging methods known as PET and MRI to improve detection of cancerous tissue better than the types of imaging that are currently available.

These methods are conducted on the same machine as conventional MRI that uses a powerful magnet, radio waves, and a computer to create detailed images. Both the PET and MRI methods look at the number of proteins a tumor has. The more proteins, the more likely there is tumor relative to normal brain tissue.

Objective
The main objective of this research is to provide proof of concept for the acquisition of MR-CEST and 18F-Fluciclovine PET and initial imaging tumor feature characterization in a small sample of patients in the post-radiation and immunotherapy period of their brain tumor management.

Treatment Radiation: F-Fluciclovine radiotracer

Key Eligibility Inclusion Criteria:



    Age 18 years or older

    Able and willing to provide informed consent

    Has a brain metastasis diagnosis with at least one single visible contrast enhancing metastatic lesion on brain MRI

    Currently receiving at least one immune checkpoint inhibitor for treatment of the malignancy

    Any other concurrent therapy or prior administered therapy, which would include prior surgery, radiation, immunotherapy, or chemotherapy are not an exclusion.

    Has had at least one previous standard-of-care MRI imaging within the past 60 days for assessment of disease location and extent with increasing enhancement where the question of tumor recurrence versus treatment related change are a clinical question.

    Be able to lie still for 30-60 minutes during the imaging procedure

    Willing and able to undergo PET/MRI

Exclusion Criteria:


    Subject unable or unwilling to provide informed consent

    Subject is pregnant

    Subject with contraindication(s) to or inability to undergo a PET or MRI

    Known allergy to 18F-Fluciclovine or any of its excipients

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
UW Health University Hospital : Jenn Cava; Wisconsin Institute for Medical Research (WIMR) : Jenn Cava