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Surgical Resection for Brain Cancer

N/A

Recruiting

Led By Elizabeth Maher, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance status > 70%

Pre-operative brain MR imaging suggestive of a brain tumor or pre-operative imaging showing a tumor or biopsy of a tumor mass prior to planned resection of the mass

Must not have

Karnofsky Performance status < 70%

NYHA class III and IV congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at end of follow-up period- between days 1-14

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the correlation between the metabolic phenotype of a brain tumor and the tumor's histopathological diagnosis. The trial will also study the correlation between the metabolic phenotype and the patient's response to treatment and overall survival.

Who is the study for?

This trial is for individuals of any age with a brain tumor, who can consent to the study or have a guardian who can. They must not be pregnant, should be in relatively good health (Karnofsky Performance status > 70%), and able to undergo MRI scans unless they have certain medical devices or severe claustrophobia.

What is being tested?

The trial involves surgical removal of the brain tumor while also studying its metabolism using a special form of glucose during surgery. The metabolic profile will be compared with high-resolution imaging before surgery and molecular analysis after, aiming to better understand the tumor's characteristics.

What are the potential side effects?

Since this study focuses on observation rather than treatment, side effects are primarily related to standard risks associated with surgical resection of brain tumors which may include bleeding, infection, neurological deficits depending on the tumor location.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly independent and can care for myself.

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My brain scans suggest a tumor or I've had a biopsy confirming a tumor before planned surgery.

Exclusion Criteria

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

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I need assistance with my daily activities.

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I have severe heart failure.

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I have unstable chest pain.

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I cannot give consent myself, nor can my guardian.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of follow-up period- between days 1-14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of follow-up period- between days 1-14

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of follow-up period- between days 1-14 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

metabolic phenotype correlation to clinical endpoints

Secondary study objectives

baseline imaging data review

molecular profiling

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: surgical resection of a brain tumorExperimental Treatment1 Intervention

The patient will undergo surgical removal of the tumor after infusion of 13C-glucose using standard neurosurgical technique, including frameless stereotaxy for surgical navigation, and microsurgical technique. --------------------------------------------------------------------------------

0 / 6Eligibility criteria met