Malignant Brain NeoplasmPhase 2NCT06667726
An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors
A Phase 2 study testing Computed Tomography, Fluorodopa F 18 and Positron Emission Tomography in people with Malignant Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Neoplasm
- What is being tested?
- Computed Tomography, Fluorodopa F 18 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 May 2028
- Phase
- Phase 2
- 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 and older
- Diagnosis of a brain tumor
- Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring
- Ability to give appropriate consent or have an appropriate representative available to do so
Who cannot join
- Patient is unable to undergo PET imaging
- Persons who are pregnant or nursing
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Derek R. Johnson, MD
About this study
Official title: A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors
This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).
II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.
OUTLINE:
Patients receive 18F-DOPA intravenously (IV) and undergo PET/CT over 30 minutes on day 1.
After completion of study intervention, patients are followed for 3 days.
- Conditions
- Malignant Brain Neoplasm
- Being tested
- Computed Tomography, Fluorodopa F 18, Positron Emission Tomography
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Fluorodopa F 18Drug
Also called (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-DOPA) | Experimental | Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1. Receives: Procedure: Computed Tomography; Drug: Fluorodopa F 18; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of 18F-DOPA PET/CT on clinical management
Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.
Measured: 3 days post-PET scan, up to 64 days
Secondary outcomes (2)
Incidence of adverse events
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 3 days post-PET scan, up to 64 days
Rate of identification of tumor outside of standard magnetic resonance imaging (MRI)
Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no (including whether a tumor outside of MRI contrast enhancement was identified); and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.
Measured: 3 days post-PET scan, up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start24 Mar 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Derek R. Johnson, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667726
- Sponsor's protocol ID
- MC250717
- Other IDs
- 24-000426, R01FD007842
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors
- ClinicalTrials.gov ID
- NCT06667726
- Acronym / sponsor ID
- MC250717
- Conditions
- Malignant Brain Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 31 Oct 2024 (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.
This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).
II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.
OUTLINE:
Patients receive 18F-DOPA intravenously (IV) and undergo PET/CT over 30 minutes on day 1.
After completion of study intervention, patients are followed for 3 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-DOPA) | Experimental | Procedure: Computed Tomography, Drug: Fluorodopa F 18, Procedure: Positron Emission TomographyPatients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- Diagnosis of a brain tumor
- Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring
- Ability to give appropriate consent or have an appropriate representative available to do so
Key exclusion criteria (2 listed)
- Patient is unable to undergo PET imaging
- Persons who are pregnant or nursing
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (18F-DOPA) |
| Fluorodopa F 18Also: (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanineGiven IV | Drug | Diagnostic (18F-DOPA) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Diagnostic (18F-DOPA) |
Primary outcome
Impact of 18F-DOPA PET/CT on clinical management
Time frame: 3 days post-PET scan, up to 64 days
Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.
2 secondary outcomes
Incidence of adverse events
Time frame: 3 days post-PET scan, up to 64 days
Rate of identification of tumor outside of standard magnetic resonance imaging (MRI)
Time frame: 3 days post-PET scan, up to 64 days
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 28 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Derek R. Johnson, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed Tomography, Fluorodopa F 18 and Positron Emission Tomography in people with Malignant Brain Neoplasm, run by Mayo Clinic 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 4 inclusion and 2 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 28 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of 18F-DOPA PET/CT on clinical management (time frame: 3 days post-PET scan, up to 64 days). 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 28 Apr 2026.