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Investigational Imaging Technique for Brain Cancer

N/A

Waitlist Available

Led By Jeffrey J. Olson, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging technique to see if it is safe and reliable for finding brain tumors and their margins during surgery.

Who is the study for?

This trial is for adults (18+) who need brain surgery within the next 14 days for a new or worsening glioblastoma, astrocytoma, or oligodendroglioma. Participants must understand the study's nature and agree to its procedures. Those only needing a needle biopsy or with serious health issues like uncontrolled infection, heart problems, or mental illness that could limit compliance are excluded.

What is being tested?

The trial tests a new imaging technique called quantitative oblique back-illumination microscopy (qOBM) during brain surgery. It aims to safely and reliably identify tumor edges in patients undergoing craniotomy—a surgical procedure to remove part of the skull to access the brain.

What are the potential side effects?

Since qOBM is an imaging technique used during surgery rather than a drug, it may not have typical side effects. However, risks may include potential complications from extended surgery time if qOBM prolongs the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Incidence of Adverse Events

Reliability of Quantitative Oblique Back Illumination Microscopy Device Determined by Central Tendency

Poisoning, Illuminating Gas

+2 more

Secondary study objectives

Microscopy

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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 (qOBM)Experimental Treatment2 Interventions

Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qOBM. Patients then undergo postoperative exam with CT or MRI any of days 1-5 after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Craniotomy

2016

N/A

~740

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