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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06159335
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Veronesi, MD, PhD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastasis, Radiation Therapy, Immunotherapy, Active
Additional Details

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.

Arms & Interventions

Arms

Experimental: PET-MRI

Participants will undergo F-Fluciclovine PET radiotracer and MRI

Interventions

Radiation: - F-Fluciclovine radiotracer

Participants will receive PET radiotracer and MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin

Madison, Wisconsin, 53705

Site Contact

Suzanne Hanson

shanson@uwhealth.org

608-263-9179

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