Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06161610

Recurrent High Grade Glioma Treated by LITT

Led by Beijing Tiantan Hospital · Updated on 2024-11-29

135

Participants Needed

9

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are: * The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments. * The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

CONDITIONS

Official Title

Recurrent High Grade Glioma Treated by LITT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years old or above
  • Previous pathological diagnosis of WHO CNS5 grade 3 or 4 glioma
  • Meet at least one progression criteria: RANO 2.0 disease progression, imaging indicating progression, pathology showing progression or recurrence, or progression as determined by Clinical Events Committee
  • All tumor lesions located supratentorial with maximum cross-sectional short-axis length ≤30 mm
  • Karnofsky Performance Score (KPS) ≥ 60 and able to tolerate intervention
  • Ability to understand the trial purpose, comply with protocol, and provide informed consent
Not Eligible

You will not qualify if you...

  • Patients who may benefit from other treatments or not benefit from this trial
  • Craniotomy within the past 3 months
  • Unable to undergo MRI contrast
  • Severe coagulation disorder
  • Pregnant, lactating, or planning pregnancy within 6 months
  • Participation in other drug or device clinical trials within 3 months
  • Presence of diseases interfering with treatment or prognosis assessment
  • Refusal or inability to complete follow-up assessments
  • Other conditions deemed inappropriate for participation by the researcher

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Not Yet Recruiting

3

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

4

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

5

Tongji Hospital

Wuhan, Hubei, China

Actively Recruiting

6

The First Hospital of Jilin University

Changchun, Jilin, China

Actively Recruiting

7

The Peoples Hospital of Liaoning

Shenyang, Liaoning, China

Actively Recruiting

8

Qilu Hospital

Jinan, Shandong, China

Actively Recruiting

9

Huashan Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

Y

Yunke Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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