What side effects are associated with this type of intervention?

Common treatments for malignant glioma, such as radiation therapy and chemotherapy, can cause side effects including headaches, scalp pain, feeling cold, neck pain, and heaviness of the head. Chemotherapy agents like bevacizumab and lomustine may lead to serious toxicities such as diarrhea, hand-foot syndrome, fatigue, and rash. Radiation therapy can result in focal tumor recurrence and other localized adverse effects. PET imaging with 18F-DOPA, used for tumor detection, is generally well-tolerated but may involve mild discomfort or allergic reactions to the tracer.

What prior FDA approvals exist?

FDA-approved treatments for malignant glioma have included various imaging and radiolabeled compounds. One notable example is the use of iodine-125 labeled monoclonal antibody 425, which targets the epidermal growth factor receptor (EGFR) and has been used in conjunction with surgical resection and radiation therapy. This approach, similar to the 18F-DOPA-PET trial, leverages radiolabeled compounds for both therapeutic and diagnostic purposes. Additionally, motexafin gadolinium has been studied in combination with stereotactic radiosurgery for glioblastoma multiforme, highlighting the ongoing exploration of advanced imaging techniques in the treatment of malignant gliomas.

What other types of research exist?

Promising novel alternatives to 18F-DOPA-PET for malignant glioma patients include [18F]FE@SUPPY, [18F]-Fluoroalkylazides, 68Ga-radiolabeling of PSMA-HBED-CC, and [18F]-DPA-714. These tracers have shown potential in tumor detection, with high tumor uptake and favorable imaging characteristics.

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18F-DOPA-PET Scan for Brain Tumor

Phase 2

Waitlist Available

Led By Nadia Laack

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Histologically confirmed newly diagnosed grade IV malignant glioma (Note: grade III patients are no longer being enrolled)

Be older than 18 years old

Must not have

Patients diagnosed with anaplastic oligodendroglioma

Men or women of childbearing potential who are unwilling to employ adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well a special brain scan can find tumors in patients with recent brain tumor diagnoses undergoing radiation therapy. The goal is to help doctors predict treatment response and plan the best treatment.

Who is the study for?

This trial is for adults with a new diagnosis of grade IV malignant glioma who can give consent, complete questionnaires, and undergo all required imaging at Mayo Clinic locations. It's not for those with anaplastic oligodendroglioma, unable to have MRI with contrast, pregnant or nursing women, or those not using birth control.

What is being tested?

The study tests how well 18F-DOPA-PET scans identify tumors in patients receiving radiation therapy for newly diagnosed gliomas. The goal is to see if these scans before and during treatment can predict outcomes and guide therapy planning.

What are the potential side effects?

Potential side effects are related to the PET scan procedure which may include discomfort from lying still during the scan. Temozolomide chemotherapy could cause nausea, fatigue, hair loss among others. Radiation therapy might lead to skin irritation or fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is a grade IV malignant brain tumor.

Exclusion Criteria

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

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I have been diagnosed with anaplastic oligodendroglioma.

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I am of childbearing age and do not plan to use birth control.

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I am currently breastfeeding.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)

Secondary study objectives

Overall Survival

Progression Free Survival

Quality of Life Evaluated With the MD Anderson Symptom Inventory Brain Tumor Module and Mini-Mental Status Exam Questionnaires

Other study objectives

Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation

Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation

Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning

+6 more

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: Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)Experimental Treatment7 Interventions

Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Perfusion Magnetic Resonance Imaging

2008

Completed Phase 2

~50

Diffusion Weighted Imaging

2006

Completed Phase 2

~150

Positron Emission Tomography

2011

Completed Phase 2

~2200

Fluorine F 18 Fluorodopa

2017

Completed Phase 2

~30

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2140

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Malignant Glioma include radiation therapy and advanced imaging techniques like PET scans. Radiation therapy targets and damages the DNA of cancer cells, preventing them from replicating and causing cell death. PET imaging, using tracers like Fluorine F 18 Fluorodopa (18F-DOPA), detects tumors by highlighting areas with increased amino acid metabolism, which is typically higher in malignant cells. This precise detection is crucial for accurately targeting radiation therapy, thereby improving treatment planning and potentially leading to better outcomes for patients with Malignant Glioma.