Adult Anaplastic AstrocytomaEarly Phase 1NCT01165632
Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma
A Early Phase 1 study testing biopsy, computed tomography and therapeutic conventional surgery in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
- What is being tested?
- biopsy, computed tomography and therapeutic conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2010to 26 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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.
- MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
- Planned craniotomy and resection or biopsy
- Willing to sign release of information for any radiation and/or follow-up records
- Negative pregnancy test done =< 48 hours of injection of study drug, for women of childbearing potential only
- Provide informed written consent
- Patients with eGFR < 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.
Who cannot join
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
- Unable to undergo an 18F-FDOPA 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 of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors
RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
Read the detailed description
PRIMARY OBJECTIVES:
- To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
- To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE:
Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
After completion of study treatment, patients are followed up every year for 5 years.
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma
- Being tested
- biopsy, computed tomography, therapeutic conventional surgery, radiation therapy treatment planning/simulation, radiation therapy
- Medical subject headings
- Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Glioma, Subependymal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
Also called biopsies
Correlative studies
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo computed tomography
therapeutic conventional surgeryProcedure or surgery
Undergo stereotactic craniotomy
radiation therapy treatment planning/simulationRadiation
Undergo radiation therapy treatment planning/simulation
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo magnetic resonance imaging
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo positron emission tomography
fluorine F 18 fluorodopaDrug
Also called (18)F-FDOPA, 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy. Receives: Procedure: biopsy; Procedure: computed tomography; Procedure: therapeutic conventional surgery; Radiation: radiation therapy treatment planning/simulation; Radiation: radiation therapy; Procedure: magnetic resonance imaging; Procedure: positron emission tomography; Drug: fluorine F 18 fluorodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
Measured: Up to 2 years
18F- FDOPA-PET metabolic imaging information
Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
Measured: Up to 2 years
Secondary outcomes (3)
Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
Measured: Up to 2 years
With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information
Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.
Measured: 2 Years
18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies
Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study start26 Jul 2010
- Primary completion5 Nov 2013
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Anaplastic AstrocytomaStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia N. Laack, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165632
- Sponsor's protocol ID
- MC1078
- Other IDs
- NCI-2010-01607, 10-001904, MC1078
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2010
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors
- ClinicalTrials.gov ID
- NCT01165632
- Acronym / sponsor ID
- MC1078
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Jul 2010 (actual)
- Primary completion
- 5 Nov 2013 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 20 Jul 2010 (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.
RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
Detailed description
PRIMARY OBJECTIVES:
- To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
- To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE:
Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
After completion of study treatment, patients are followed up every year for 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: biopsy, Procedure: computed tomography, Procedure: therapeutic conventional surgery, Radiation: radiation therapy treatment planning/simulation, Radiation: radiation therapy, Procedure: magnetic resonance imaging, Procedure: positron emission tomography, Drug: fluorine F 18 fluorodopaBeginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
- Planned craniotomy and resection or biopsy
- Willing to sign release of information for any radiation and/or follow-up records
- Negative pregnancy test done =< 48 hours of injection of study drug, for women of childbearing potential only
Key exclusion criteria (3 listed)
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
- Unable to undergo an 18F-FDOPA 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
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 |
|---|---|---|
| biopsyAlso: biopsiesCorrelative studies | Procedure or surgery | Arm I |
| computed tomographyAlso: tomography, computedUndergo computed tomography | Procedure or surgery | Arm I |
| therapeutic conventional surgeryUndergo stereotactic craniotomy | Procedure or surgery | Arm I |
| radiation therapy treatment planning/simulationUndergo radiation therapy treatment planning/simulation | Radiation | Arm I |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Arm I |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo magnetic resonance imaging | Procedure or surgery | Arm I |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo positron emission tomography | Procedure or surgery | Arm I |
| fluorine F 18 fluorodopaAlso: (18)F-FDOPA, 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPAGiven IV | Drug | Arm I |
Primary outcome
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
Time frame: Up to 2 years
Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
18F- FDOPA-PET metabolic imaging information
Time frame: Up to 2 years
Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
3 secondary outcomes
Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
Time frame: Up to 2 years
With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information
Time frame: 2 Years
18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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. This study is not recruiting at the moment.
Nadia N. Laack, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing biopsy, computed tomography and therapeutic conventional surgery in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 2 Sep 2025.