Adult Anaplastic EpendymomaNCT02175745
18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas
A study testing 18F-fluoro-dihydroxyphenylalanine, Positron emission tomography (PET) and Computed tomography (CT) in people with Adult Anaplastic Ependymoma and Adult Anaplastic Oligodendroglioma, run by Erik Mittra at 1 site in United States.
Trial summary
To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma
- What is being tested?
- 18F-fluoro-dihydroxyphenylalanine, Positron emission tomography (PET) and Computed tomography (CT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Greater than 15 year-old at the time of radiotracer administration
- Provides written informed consent
- Suspected new diagnosis or suspected recurrence of glioma
- Able to remain still for duration of each imaging procedure (about 20 minutes)
Who cannot join
- Less than 15 year-old at the time of radiotracer administra
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: 18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas
To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.
Read the detailed description
This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.
- Conditions
- Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma
- Being tested
- 18F-fluoro-dihydroxyphenylalanine, Positron emission tomography (PET), Computed tomography (CT), Magnetic resonance imaging
- Medical subject headings
- Ependymoma, Oligodendroglioma, Astrocytoma, Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms, Neoplasms, Neuroepithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluoro-dihydroxyphenylalanineDrug
Also called (18)F-FDOPA, 18F-6-L-fluorodopa, 18F-DOPA, 18F-FDOPA
Administered intravenously (IV)
Positron emission tomography (PET)Procedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Component of an 18F-FDOPA PET/CT or PET/MRI scan
Computed tomography (CT)Procedure or surgery
Also called tomography, computed, CT scan
Component of an 18F-FDOPA PET/CT
Magnetic resonance imagingProcedure or surgery
Also called MRI scan, NMR imaging, NMRI, nuclear magnetic resonance imaging
Component of an 18F-FDOPA PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (FDOPA-PET/CT or PET/MRI) | Experimental | Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later. Receives: Drug: 18F-fluoro-dihydroxyphenylalanine; Procedure: Positron emission tomography (PET); Procedure: Computed tomography (CT); Procedure: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Suspicious Lesions Identified by 18F FDOPA PET
The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.
Measured: Up to 30 minutes after injection of F18 FDOPA
Percent Agreement of 18F FDOPA PET With Pathology
For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.
Measured: Up to 30 minutes post-injection (at time of scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionDec 2015
Why it stopped: Re-evaluate indication with the referring physicians
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Anaplastic EpendymomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erik Mittra
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Erik Mittra, Stanford University
- Investigators
- Erik Mittra, MD, PhD, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175745
- Sponsor's protocol ID
- IRB-29364
- Other IDs
- NCI-2014-01289, BRN0024, P30CA124435
- Status last verified
- Jan 2017
- First submitted
- 24 Jun 2014
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas
- ClinicalTrials.gov ID
- NCT02175745
- Acronym / sponsor ID
- IRB-29364
- Conditions
- Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Re-evaluate indication with the referring physicians
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Erik MittraUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.
Detailed description
This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (FDOPA-PET/CT or PET/MRI) | Experimental | Drug: 18F-fluoro-dihydroxyphenylalanine, Procedure: Positron emission tomography (PET), Procedure: Computed tomography (CT), Procedure: Magnetic resonance imagingPatients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 15 year-old at the time of radiotracer administration
- Provides written informed consent
- Suspected new diagnosis or suspected recurrence of glioma
- Able to remain still for duration of each imaging procedure (about 20 minutes)
Key exclusion criteria (5 listed)
- Less than 15 year-old at the time of radiotracer administra
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
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 |
|---|---|---|
| 18F-fluoro-dihydroxyphenylalanineAlso: (18)F-FDOPA, 18F-6-L-fluorodopa, 18F-DOPA, 18F-FDOPAAdministered intravenously (IV) | Drug | Diagnostic (FDOPA-PET/CT or PET/MRI) |
| Positron emission tomography (PET)Also: FDG-PET, PET, PET scan, tomography, emission computedComponent of an 18F-FDOPA PET/CT or PET/MRI scan | Procedure or surgery | Diagnostic (FDOPA-PET/CT or PET/MRI) |
| Computed tomography (CT)Also: tomography, computed, CT scanComponent of an 18F-FDOPA PET/CT | Procedure or surgery | Diagnostic (FDOPA-PET/CT or PET/MRI) |
| Magnetic resonance imagingAlso: MRI scan, NMR imaging, NMRI, nuclear magnetic resonance imagingComponent of an 18F-FDOPA PET/MRI | Procedure or surgery | Diagnostic (FDOPA-PET/CT or PET/MRI) |
Primary outcome
Number of Suspicious Lesions Identified by 18F FDOPA PET
Time frame: Up to 30 minutes after injection of F18 FDOPA
The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.
Percent Agreement of 18F FDOPA PET With Pathology
Time frame: Up to 30 minutes post-injection (at time of scan)
For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Erik Mittra, MD, PhD principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluoro-dihydroxyphenylalanine, Positron emission tomography (PET) and Computed tomography (CT) in people with Adult Anaplastic Ependymoma and Adult Anaplastic Oligodendroglioma, run by Erik Mittra 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 5 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: stopped early, as of the sponsor's last update on 20 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Suspicious Lesions Identified by 18F FDOPA PET (time frame: Up to 30 minutes after injection of F18 FDOPA). 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 20 Mar 2017.