Brain MetastasisPhase 3NCT06159335
18F-FLUC PET/MR in Patients With Brain Mets
A Phase 3 study testing F-Fluciclovine radiotracer in people with Brain Metastasis and Radiation Therapy, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis, Radiation Therapy, Immunotherapy, Active
- What is being tested?
- F-Fluciclovine radiotracer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients are eligible for the study if their most recent standard-of-care MRI, used to assess disease location and extent, raises the question of tumor recurrence versus treatment-related changes. This concern can be noted by the radiologist or other members of the multidisciplinary care team, such as during a multidisciplinary conference. Additionally, if there are clinical concerns based on evolving exam findings or symptoms, and the treating physician suspects progression versus treatment-induced changes, the patient is also eligible for the study.
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- Be able to lie still for 30-60 minutes during the imaging procedure
- Willing and able to undergo PET/MRI or PET/CT
- 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
Who cannot join
- Subject unable or unwilling to provide informed consent
- Subject is pregnant
- Subject with contraindication(s) to or inability to undergo a PET/MR or PET/CT
- Known allergy to 18F-Fluciclovine or any of its excipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy
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.
Read the detailed 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.
- Conditions
- Brain Metastasis, Radiation Therapy, Immunotherapy, Active
- Being tested
- F-Fluciclovine radiotracer
- Medical subject headings
- Brain Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-Fluciclovine radiotracerRadiation
Participants will receive PET radiotracer and MRI
| Study group | Role | What they receive |
|---|---|---|
| PET-MRI | Experimental | Participants will undergo F-Fluciclovine PET radiotracer and MRI Receives: Radiation: F-Fluciclovine radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start10 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Michael Veronesi, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159335
- Sponsor's protocol ID
- 2023-1082
- Other IDs
- NCI-2024-06018, Protocol Version 11/20/2025, A539300, UW23061
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy
- ClinicalTrials.gov ID
- NCT06159335
- Acronym / sponsor ID
- 2023-1082
- Conditions
- Brain Metastasis, Radiation Therapy, Immunotherapy, Active
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MRI | Experimental | Radiation: F-Fluciclovine radiotracerParticipants will undergo F-Fluciclovine PET radiotracer and MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- Subject unable or unwilling to provide informed consent
- Subject is pregnant
- Subject with contraindication(s) to or inability to undergo a PET/MR or PET/CT
- Known allergy to 18F-Fluciclovine or any of its excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-Fluciclovine radiotracerParticipants will receive PET radiotracer and MRI | Radiation | PET-MRI |
Primary outcome
Amino acid uptake into tumor tissue
Time frame: 3 hours
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Veronesi, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F-Fluciclovine radiotracer in people with Brain Metastasis and Radiation Therapy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Studies (608-282-8349, radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid uptake into tumor tissue (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.