Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05310448

Tumor Treating Fields for the Treatment of Brainstem Gliomas

Led by Emory University · Updated on 2025-09-26

10

Participants Needed

3

Research Sites

259 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. TTFields may prevent growth or decrease size of gliomas in patients

CONDITIONS

Official Title

Tumor Treating Fields for the Treatment of Brainstem Gliomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Karnofsky performance status of 70% or higher
  • Life expectancy greater than 12 weeks as determined by the investigator
  • Diagnosis of glioma with at least partial involvement or invasion of thalamus, cerebral peduncles, midbrain, pons, or medulla; diagnosis confirmed by biopsy or maximal safe resection preferred
  • Completion of all prior cancer therapies including surgery and radiotherapy at least 4 weeks before starting study treatment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and study procedures
  • Signed informed consent acknowledging understanding of the disease and study details
  • Adequate organ and marrow function within 28 days before starting temozolomide, including specified blood counts, coagulation times, and liver and kidney function
  • Negative pregnancy test for females of child-bearing potential prior to therapy start
  • Agreement to use adequate contraception for females of child-bearing potential and men before and during study participation, and for men up to 12 months after treatment completion
Not Eligible

You will not qualify if you...

  • Completion of chemotherapy or radiotherapy more than 26 weeks before study entry
  • Receiving other investigational drugs or devices within 21 days before starting the study device
  • History of allergic reactions to compounds similar to those used for transducer placement
  • Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
  • Significant cardiovascular disease within 3 months before study start, including recent heart attack, thromboembolism, symptomatic peripheral vascular disease, severe heart failure, or uncontrolled high blood pressure
  • HIV-positive patients on combination antiretroviral therapy due to risk with marrow-suppressive therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Emory Proton Therapy Center

Atlanta, Georgia, United States, 30308

Not Yet Recruiting

2

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Not Yet Recruiting

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Research Team

J

Jim Zhong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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