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

Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159335
• Other study ID #: 2023-1082
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Suzanne Hanson
• Phone: 608-263-9179
• Email: radstudy[@]uwhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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
• Received at least one immune checkpoint inhibitor for treatment of the malignancy in the past 6 months
• 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

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Immunotherapy, Active
• Neoplasm Metastasis
• Radiation Therapy

Intervention

Radiation:
• F-Fluciclovine radiotracer
Participants will receive PET radiotracer and MRI

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amino acid uptake into tumor tissue	Using 18F-Fluciclovine PET, compare amino acid uptake into brain tumor tissue with uptake in normal brain tissue. Higher uptake is hypothesized to indicate malignancy	3 hours
Primary	Cystolic protein in tumor cells	Using MR CEST, measure the level of cystolic protein in tumor cells relative to normal brain tissue. Higher levels are hypothesized to indicate malignancy.	3 hours