Glioma
Conditions
Interventions
Intervention group:Application of 18F-FET PET to guide the entire clinical course of high-grade glioma: diagnosis, surgical resection, post-resection baseline assessment, radiotherapy, and treatment e
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–75 years with an Eastern Cooperative Oncology Group (ECOG) performance status <= 2, and suspected high-grade glioma based on contrast-enhanced brain MRI and clinical manifestations. 2. No contraindications to MRI examination. 3. No prior history of cranial radiotherapy or temozolomide (TMZ) chemotherapy. 4. Adequate bone marrow and organ function to tolerate radiotherapy and temozolomide (TMZ) chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Patients with histologically or molecularly confirmed non-high-grade glioma. 2. Presence of comorbidities that may affect trial safety or outcome assessment, such as severe infection, allergies, or psychiatric disorders. 3. History of other malignant tumors within the past 2 years (except cured basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the bladder, etc.). 4. Pregnancy, planned pregnancy, or vulnerable populations. 5. Inability to tolerate or complete the full course of radiotherapy. 6. Current participation in other clinical trials that may affect the results of this study (as determined by the principal investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) ;Overall Survival (OS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the extent of surgical resection planned based on 18F-FET PET and contrast-enhanced MRI.;Differences in radiotherapy target volumes delineated based on 18F-FET PET and contrast-enhanced MRI.;Relationship between recurrence pattern and target volume.;Accuracy of 18F-FET PET and contrast-enhanced MRI in differentiating tumor recurrence from pseudoprogression.;Radiation necrosis.;Changes in quality of life and cognitive function (EORTC QLQ-C30, MMSE).; | — |
Countries
China
Contacts
Public ContactYu Wang
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China
Outcome results
None listed