NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedglioma
Date of first enrollment23/05/2016
Target sample size90
Countries of recruitment
Study typeInterventional
Intervention(s)Usefulness of using C-11 methionine PET

Outcome(s)

Primary OutcomePositive-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 minimumNot applicable
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Nozomi Yokota
Address N14,W5,Kita-Ku, Sapporo Hokkaido Japan 060-8684
Telephone +81-11-706-7735
E-mail 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
E-mail syamama1945@gmail.com
Affiliation Hokkaido University Hospital