Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LITT | Experimental | LITT+potential other treatment |
|
| Control | Active Comparator | Best medical management under guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LITT | Device | The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation. | estimate 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion ablation rate | LITT group only, measured on enhanced MRI within 2 days post LITT | within 2 days Post LITT |
| Lesion remaining volume | LITT group only, measured on enhanced MRI within 2 days post LITT |
| Measure | Description | Time Frame |
|---|---|---|
| specific AE rate | Specific AE and complication including intracerebral hemorrhage, severe edema, newly seizure, local incision wound and all SAEs | through study completion, an average of 6 month |
| bleeding volume |
Inclusion Criteria:
Aged 18 years old or above;
Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;
Meet any of the following:
All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunke Li, MD | Contact | 0086-010-67088936 | liyunke@sinovationmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Jiang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
The progression will be assessed by third-party blinded investigators
|
| Control | Other | The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted, |
|
| within 2 days Post LITT |
| Overall survival | up to 2 years |
| Karnofsky Performance Status (KPS) shift | The difference between baseline KPS and follow-up KPS | Day 30,Day 90, Day 180 |
LITT group only during surgery
| post LITT immmediatly |
| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
|
| The Peoples Hospital of Liaoning | Recruiting | Shenyang | Liaoning | China |
|
| Qilu Hospital | Recruiting | Jinan | Shandong | China |
|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |