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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial looks at how well a PET scan using 18F-DOPA works in finding tumors in patients with newly diagnosed gliomas undergoing radiation therapy.

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.Check my eligibility

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.See study design

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

Select...

My diagnosis is a grade IV malignant brain tumor.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Overall Survival

Progression Free Survival

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

+2 more

Other outcome measures

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

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

Positron Emission Tomography

2008

Completed Phase 2

~2240

Temozolomide

2010

Completed Phase 3

~1930

Diffusion Weighted Imaging

2006

Completed Phase 2

~150

Fluorine F 18 Fluorodopa

2017

Completed Phase 2

~30

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Perfusion Magnetic Resonance Imaging

2008

Completed Phase 2

~50

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,049 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,396 Total Patients Enrolled

Nadia LaackPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

92 Total Patients Enrolled

Media Library

Temozolomide Clinical Trial Eligibility Overview. Trial Name: NCT01991977 — Phase 2

Malignant Glioma Research Study Groups: Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Malignant Glioma Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT01991977 — Phase 2

Temozolomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT01991977 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial the inaugural example of its kind?

"Since first being studied in 2002, Intensity-Modulated Radiation Therapy has made great strides. The initial clinical trial, sponsored by Schering-Plough and involving 60 participants, granted the drug its Phase 2 approval. Currently, 207 trials are underway for this therapy across 935 cities and 36 nations."

Answered by AI

What maladies is Intensity-Modulated Radiation Therapy commonly deployed to address?

"Intensity-Modulated Radiation Therapy, which is regularly utilized to treat nitrosourea treatment, has also proven its efficacy in the management of refractory directives, advanced mycosis fungoides, and recalcitrant neuroblastomas."

Answered by AI

Have there been any previous investigations into the efficacy of Intensity-Modulated Radiation Therapy?

"At present, there are 207 trials in progress for Intensity-Modulated Radiation Therapy with 24 of them currently at Phase 3. Though many clinical studies related to IMRT are conducted in Seoul and Songpa, the therapy is being tested all around the world - 4752 locations to be exact."

Answered by AI

What is the estimated number of participants currently enrolled in this investigation?

"The editing history on clinicaltrials.gov indicates that recruitment for this particular trial is no longer active; the initial post was made December 1st 2013 and it was last edited July 15th 2022. For those seeking alternative trials, 353 studies are recruiting glioma patients while 207 medical centres have open positions to study Intensity-Modulated Radiation Therapy."

Answered by AI

Is enrollment for this experiment still available?

"Per the information recorded on clinicaltrials.gov, this particular medical trial is no longer enrolling patients; it was initially posted December 1st 2013 and its last update occurred July 15th 2022. Nonetheless, there are 560 other trials actively seeking participants currently."

Answered by AI

Has the FDA certified Intensity-Modulated Radiation Therapy for therapeutic use?

"Despite there not being any clinical data that confirms the efficacy of Intensity-Modulated Radiation Therapy, a score of 2 was assigned due to existing safety studies."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Initial Results of a Phase 2 Trial of 18F-DOPA Pet-guided Dose-escalated Radiation Therapy for Glioblastoma

Laack, Nadia Nicole, Deanna Pafundi, S. Keith Anderson, Timothy Kaufmann, Val Lowe, Christopher Hunt, Diane Vogen, et al.. 2021. “Initial Results of a Phase 2 Trial of 18F-DOPA Pet-guided Dose-escalated Radiation Therapy for Glioblastoma”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2021.03.032.

clinicaltrials.govStudy

18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy

2013. "18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01991977.

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