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

Phase 1

Recruiting

• Conditions: Diffuse midline glioma,Deep seated glioma

• Registration Number: JPRN-jRCTs032230489
• Lead Sponsor: Tsurubuchi Takao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-04
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion 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
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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction rate of progression of DMG or DSG using 18F-BPA PET high uptake lesion

Secondary Outcome Measures

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