Glioma
Conditions
Interventions
For non-enhancing glioma at the time of initial diagnosis, 1) Intravenous administration of single-dose gadoteridol (0.2 ml/kg body weight) 2) Acquisition of T1-weighted MR images within 10 minute
Sponsors
Tokyo Women's Medical University
Kizawa Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)age of the patient from 20 to 65 years (2)newly diagnosed intraaxial non-enhancing glioma (3)agreement of the patient and his or her nearest family member for participation in the study and informed consent for neuroradiological investigation (4)absence of contraindications for contrast-enhanced MRI and PET investigations, such as -implanted heart pacemaker device -intravascular stents (any location) -intracranial vascular clips -cochlear implants -crystalline lens protheses -other implanted ferromagnetic objects or magnetically/mechanically activated devices (5)absence of the history of anaphylactoid reactions, respiratory difficulties, respiratory allergic disease, and adverse reactions to iodinated contrast media (6)absence of pregnancy and lactation (7)absence of diabetes mellitus and any decompensated chronic diseases (8)normal renal function -absence of positive risk factors for renal insufficiency (kidney disease, previous renal surgery, proteinuria, diabetes mellitus, arterial hypertension, gout) -normal level of serum creatinine (men: 0.69-1.06 mg/dl, women: 0.48-0.79 mg/dl) -estimated glomerular filtration rate >70ml/min/1.73m2 (9)initiation of the diagnostic work-up and treatment within the study period
Exclusion criteria
Exclusion criteria: (1) presence of contrast enhancement on T1-weighted 1.5 T MRI after intravenous administration of single-dose (0.2 ml/kg) gadoteridol; these patients will be enrolled into full investigational protocol but their data will be analyzed separately; (2) absence of surgical treatment in TWMU within 1 month after completion of the neuroradiological investigation; (3) establishment of any histpathological diagnosis after resective surgery other than glioma of astrocytic, oligodendroglial, or ependymal origin, neuronal or mixed neuronal-glial neoplasm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological characteristics of glioma | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Countries
Japan
Outcome results
None listed