A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2031-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Fluorine-18-L-dihydroxyphenylalanine

Intervention Type DRUG

5 millicuries ± 10%; Intravenous injection; 1 time

Interventions

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Fluorine-18-L-dihydroxyphenylalanine

5 millicuries ± 10%; Intravenous injection; 1 time

Intervention Type DRUG

Other Intervention Names

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18F-DOPA FDOPA

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No