Malignant GliomaNCT02104310
A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas
An observational study of Malignant Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Fluorine-18-L-dihydroxyphenylalanine
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2014to Mar 2031
- Phase
- Observational
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed or recurrent WHO Grade II and Grade III Glioma patients.
Who may be able to join
- Age ≥7 years.
- Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
- CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
- Willing to sign release of information for any follow-up records.
- Provide informed written consent.
Who cannot join
- Patients diagnosed with WHO grade IV malignant glioma.
- Patients previously treated with radiation therapy.
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
- Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.
- Conditions
- Malignant Glioma
- Being tested
- Fluorine-18-L-dihydroxyphenylalanine
- Keywords
- malignant glioma, FDOPA, PET CT, radiation therapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorine-18-L-dihydroxyphenylalanineDrug
Also called 18F-DOPA, FDOPA
5 millicuries ± 10%; Intravenous injection; 1 time
| Study group | Role | What they receive |
|---|---|---|
| Fluorine-18-L-dihydroxyphenylalanine | 18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure Receives: Drug: Fluorine-18-L-dihydroxyphenylalanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment volume comparison
The primary endpoint for this pilot study will be to compare radiotherapy treatment volumes defined by conventional MR-only with treatment volumes defined with both 18F-DOPA PET and conventional MR information
Measured: 6 weeks
Secondary outcomes (2)
Advanced imaging volume comparison
For patients who have advanced MRI scans performed as part of standard clinical care, advanced MRI volumes will be compared with conventional MRI volumes as well as 18F-DOPA PET volumes
Measured: 6 weeks
Concordance with recurrence
For patients who progress radiographically within the observation period of this study will compare concordance of recurrence locations with pre-treatment 18F-DOPA PET uptake
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start8 Apr 2014
- Primary completion26 Mar 2021
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Brains Together for the Cure
- Responsible party
- Sponsor
- Investigators
- Nadia N Laack, MD, Principal investigator, Mayo ClinicDebra Brinkmann, PhD, Principal investigator, Mayo ClinicDeanna Pafundi, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104310
- Sponsor's protocol ID
- 11-002165
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2014
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT02104310
- Acronym / sponsor ID
- 11-002165
- Conditions
- Malignant Glioma
- Keywords
- malignant glioma, FDOPA, PET CT, radiation therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Brains Together for the Cure
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- Mar 2031 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- 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.
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorine-18-L-dihydroxyphenylalanine | – | Drug: Fluorine-18-L-dihydroxyphenylalanine18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed or recurrent WHO Grade II and Grade III Glioma patients.
Key inclusion criteria (5 listed)
- Age ≥7 years.
- Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
- CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
- Willing to sign release of information for any follow-up records.
- Provide informed written consent.
Key exclusion criteria (7 listed)
- Patients diagnosed with WHO grade IV malignant glioma.
- Patients previously treated with radiation therapy.
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
- Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
- Pregnant women
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 |
|---|---|---|
| Fluorine-18-L-dihydroxyphenylalanineAlso: 18F-DOPA, FDOPA5 millicuries ± 10%; Intravenous injection; 1 time | Drug | Fluorine-18-L-dihydroxyphenylalanine |
Primary outcome
Treatment volume comparison
Time frame: 6 weeks
The primary endpoint for this pilot study will be to compare radiotherapy treatment volumes defined by conventional MR-only with treatment volumes defined with both 18F-DOPA PET and conventional MR information
2 secondary outcomes
Advanced imaging volume comparison
Time frame: 6 weeks
Concordance with recurrence
Time frame: up to 10 years
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 6 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Nadia N Laack, MD principal investigator
Mayo Clinic
Debra Brinkmann, PhD principal investigator
Mayo Clinic
Deanna Pafundi, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma, 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 6 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment volume comparison (time frame: 6 weeks). 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 6 Apr 2026.