JRCT ID: jRCTs012180017
Registered date:19/03/2019
Usefulness of using C-11 methionine PET in patient which suspected glioma
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | glioma |
Date of first enrollment | 23/05/2016 |
Target sample size | 90 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Usefulness of using C-11 methionine PET |
Outcome(s)
Primary Outcome | Positive-predictive value (PPV) in the site of negative contrast-enhanced MRI and positive Met-PET which assume a histopathology diagnosis criteria diagnosis. |
---|---|
Secondary Outcome | (1) Rate of cases where Met-PET positive area is equivalent to MRI enhanced area (2)Rate of cases where tumor exists in the area of MRI-positive and Met-PET-negative findings. (3)Safety: Presence/absence and details of the adverse event, including abnormal changes of vital signs and laboratory data. |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
---|---|
Age maximum | Not applicable |
Gender | Both |
Include criteria | (1)The patients whose doctor plans a biopsy or tumor resection and whose tumor is suspected as primary glioma by board-certified diagnostic radiologists and board-certified neurosurgeons based on clinical manifestations, clinical courses, and MRI findings. (2)The patients who or whose legal representative gave a written informed consent to this study. |
Exclude criteria | (1)The patients with a history of serious allergic reaction to C-11 methionine or F-18 FDG. (2)Pregnant women, breast-feeding women, or women who may be pregnant (3)The patients who is participating in other trials (4)The patients who underwent C-11 methionine PET within 90 days (5)The patients whose overall status is not satisfactory for surgical treatment (6) The patients who cannot undergo contrast-enhanced MRI (7) The patients whom investigators judged to be inadequate as candidates |
Related Information
Primary Sponsor | Yamaguchi Shigeru |
---|---|
Secondary Sponsor | Shiga Toru |
Source(s) of Monetary Support | Sumitomo Heavy Industries, Ltd.,Japan Agency for Medical Research and Development |
Secondary ID(s) | UMIN000022067 |
Contact
Public contact | |
Name | Nozomi Yokota |
Address | N14,W5,Kita-Ku, Sapporo Hokkaido Japan 060-8684 |
Telephone | +81-11-706-7735 |
nozomi.yokota@huhp.hokudai.ac.jp | |
Affiliation | Hokkaido University Hospital |
Scientific contact | |
Name | Shigeru Yamaguchi |
Address | N14,W5,Kita-Ku, Sapporo Hokkaido Japan 060-8648 |
Telephone | +81-11-706-5987 |
syamama1945@gmail.com | |
Affiliation | Hokkaido University Hospital |