Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating P… (NCT01165632) | Clinical Trial Compass
CompletedEarly Phase 1
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
United States24 participantsStarted 2010-07-26
Plain-language 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.
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a special type of PET scan called 18F-FDOPA to help plan surgery and radiation — is this kind of imaging scan now available at our hospital as part of standard care, or is it still mainly a research tool?
2Since this was an early Phase 1 study that's already completed, what did doctors learn from it about whether 18F-FDOPA PET scans show brain tumor boundaries more accurately than a regular MRI, and could that information change how my treatment would be planned?
3The trial enrolled people with a wide range of glioma types, from low-grade to glioblastoma — given my specific diagnosis, do you think the 18F-FDOPA imaging approach tested here would be particularly relevant to my situation?
4Because this study is finished and was an early-phase trial focused on gathering imaging information rather than testing a treatment, are there follow-on trials or current clinical options that build on what this research found that might be worth considering for me?
5Would adding an 18F-FDOPA PET scan to my pre-surgical workup be something you'd recommend discussing with my surgical and radiation team, based on what this trial and similar studies have shown?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies