The study of Prediction of progression of DMG and DSG using MRI-FBPA PET

JRCT ID: jRCTs032230489

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diffuse midline glioma,Deep seated glioma
• Date of first enrollment: 04/12/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

The properties of 18F-BPA PET about the prediction of progression of DMG or DSG lesions at pretreatment status
Multi-institutional joint research

Outcome(s)

• Primary Outcome: Prediction rate of progression of DMG or DSG using 18F-BPA PET high uptake lesion

Secondary Outcome

Overall Survival
Progression free survival
The status of H3K27-altered in Immunohistochemical staining of the surgical specimens
RIng-like enhancement or T2WI high intensity lesions
The maximal diameter of the tumor on the pretreatment MRI
The tumor volume showing 18F-BPA PET hot uptake lesions at pretreatment state
18F-BPA PET uptake avidity
The relationship between H3K27-altered status and prognosis
The prediction rate of progression of DMG or DSG using 11C-MET-PET hot uptake lesions or 18F-BPA PET hot uptake lesions
The differences between tumor volume showing 18F-BPA PET hot uptake lesions and the progressive lesions on MRI
The evaluation of the property between 18F-BPA PET and 11C-MET PET

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Diffuse Midline Glioma patients showing T2WI high intensity lesions in hypothalamus or Thalamus or Brain stem or spinal cord
Deep Seated Glioma patients
Diagnosed as Glioma preoperatively together with Gadolinium ring-like enhanced lesions on pretreatment MRI
Age :16 y.o. over and 75 y.o. under
Within 6 weeks after tumor biopsy or tumor partial removal (If surgery was done)
Completion of initial treatment including surgery, chemotherapy and/or radiation therapy
Perfotmance status socore 3 under by ECOG criteria
Labo data within 2 weeks showing
Neutrophil 1,500/mm3 over
Hemoglobin 8.0 g/dL over
Platelets 10x10^4/mm3 over
AST(GOT) 120 IU/L under
ALT(GPT) 120 IU/L under
eGFR 45 mL/min/1.73m2 over

Exclude criteria

DMG patients showing H3K27 wild type on surgical specimens
DSG patients showing IDH mutant on surgical specimens
WHO grade 2 or grade 1
previous chemotherapy or previous radiation therapy
CSF dissemination including ventricle or cerebellum or brain stem or spinal cord
active cancer lesions
active cardiac disease
phenylketonuria
pregnant or during breast feeding
Given other trial drugs within 3 months
HIV antibody positive
HBs antigen positive
Inappropriate judged by our doctors

Related Information

• Primary Sponsor: Sugii Narushi
• Source(s) of Monetary Support: University of Tsukuba Hospital