← Back to Search

18F-DOPA-PET Scan for Brain Tumor

Phase < 1

Waitlist Available

Led By Nadia N. Laack, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Ability to provide tissue for mandatory correlative research component

Planned craniotomy and resection or biopsy

Must not have

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

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 uses a new imaging procedure, 18F-DOPA-PET scan, to help find and plan surgery for gliomas.

Who is the study for?

This trial is for patients with new or returning gliomas who can undergo MRI scans and surgery. They must be willing to provide tissue samples, sign a release for medical records, and use contraception if of childbearing potential. It's not suitable for those unable to have MRI with contrast, nursing women, pregnant women, or individuals on certain dopamine-related medications.

What is being tested?

The study tests the effectiveness of using an imaging procedure called 18F-DOPA-PET in planning surgeries for glioma patients. This involves comparing traditional methods like biopsy and CT scans with this advanced PET scan technique to see if it improves surgical outcomes.

What are the potential side effects?

While the trial focuses on imaging techniques rather than drugs, side effects may include discomfort from the biopsy procedure, reactions to contrast agents used in MRI and PET scans such as mild allergic reactions or kidney issues in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can provide a tissue sample for research.

Select...

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

Select...

My MRI shows I have a new or returning brain tumor.

Exclusion Criteria

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

Select...

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

Select...

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

Select...

I am currently breastfeeding.

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

Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N

Secondary study objectives

Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI

Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue

MRI contrast enhancement values

+1 more

Other study objectives

Accurate identification of the highest grade/highest density disease

Accurate identification of tumor extent

Role of metabolic imaging in neurosurgical resection planning

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT02150213

Renal Cyst

Adrenal Adenoma

Angiomyolipoma

Ovarian cyst

100%

80%

60%

40%

20%

Study treatment Arm

BGG492

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 (18F-DOPA-PET)Experimental Treatment8 Interventions

Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diffusion Weighted Imaging

2006

Completed Phase 2

~150

Biopsy

2014

Completed Phase 4

~1090