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F-18 Fluorodopa PET Scan for Brain Tumor

Phase < 1

Waitlist Available

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned craniotomy and resection or biopsy

MRI findings compatible with newly diagnosed high- or low-grade malignant glioma

Must not have

Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)

Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well fluorine F 18 fluorodopa-labeled PET scan works in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma.

Who is the study for?

This trial is for adults over 18 with a new diagnosis of high or low-grade malignant glioma, who are planning to have brain surgery (craniotomy and resection or biopsy). Participants must be able to provide medical records and consent. Women capable of becoming pregnant must test negative for pregnancy within 48 hours before receiving the study drug.

What is being tested?

The trial studies how well a special PET scan using fluorine F 18 fluorodopa works in planning surgical and radiation treatments for brain tumors. It aims to improve treatment by providing better imaging techniques to guide doctors during these procedures.

What are the potential side effects?

While not directly related to side effects from medications, this trial involves exposure to radiation through PET scans and potential risks associated with magnetic resonance imaging (MRI), surgery, and radiation therapy which can include discomfort, bleeding, infection, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for brain surgery to remove or sample a tumor.

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My MRI shows I might have a serious brain tumor.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have MRI scans with contrast due to a condition like having a pacemaker or kidney failure.

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I am not pregnant, nursing, or if capable of childbearing, I am willing to use contraception.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18F- FDOPA-PET metabolic imaging information

18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

Secondary study objectives

18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies

Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm IExperimental Treatment8 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

biopsy

2002

Completed Phase 4

~8270

therapeutic conventional surgery

2003

Completed Phase 3

~12900