RECRUITING

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

Conditions

Brain Metastasis Radiation Therapy Immunotherapy, Active

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to use new imaging methods to help in finding out whether the imaging shows that there is a tumor in people with a brain metastasis. The main question it aims to answer is whether positron emission tomography (PET) and magnetic resonance imaging (MRI) find cancerous tissue better than other types of imagining. Participants will undergo a single PET/MRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.

Official Title

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

Quick Facts

Study Start:2024-01-10

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06159335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Received radiation therapy at some point in the last 2 years * Is currently being treated with or has been treated with any other concurrent systemic therapy (multi-modal therapy) in the past 6 months, which would include immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or chemotherapy following radiation therapy. * 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 * Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met: * The subject has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of this medication * They come to the research visit with a driver	* 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

Inclusion Criteria

Exclusion 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
* Received radiation therapy at some point in the last 2 years
* Is currently being treated with or has been treated with any other concurrent systemic therapy (multi-modal therapy) in the past 6 months, which would include immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or chemotherapy following radiation therapy.
* 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
* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
* The subject has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* They come to the research visit with a driver

* 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

Contacts and Locations

Study Contact

Suzanne Hanson

CONTACT

608-263-9179

radstudy@uwhealth.org

Principal Investigator

Michael Veronesi, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Michael Veronesi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-10

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Brain Metastasis
Radiation Therapy
Immunotherapy, Active