Detection of recurrence after radiation therapy using C-11 methionine PET
- Conditions
- Primary or secoundary brain tumor, Tumor of the neighboring organ
- Registration Number
- JPRN-jRCTs012180018
- Lead Sponsor
- Shigeru Yamaguchi
- Brief Summary
C-11 methionine-PET test using a new methionine-dedicated synthesizer is clinically useful in diagnosing recurrence of brain tumors after radiation therapy, and it can be easily performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 59
(1)
The patients with suspected recurrence of tumor more than a half year after radiation theray
(2)
The patients that enough diagnosis information is not obtained by the common imaging (CT, MRI)
(3)
The patients or the patients that a written agreement is obtained about participation of this study by legal representative
(1)
The patients with a history of serious hypersensitivity for C-11 methionine or F-18 FDG.
(2)
A pregnant woman, nursing mother and the women who may be pregnant
(3)
The patients who participate in other trials
(4)
The patients who receive C-11 methioine PET within 90 days
(5)
The patients whom it is assumed overall status to have difficulty in application of the surgical treatment
(6)
The patients whom brain metastasis appeared outside of radiation fields
(7)
The patients that a primary tumor and other metastases caused exacerbation for a metastatic brain tumor remarkably
(8)
The patients whom it was multiple, and metastasis appeared for a primary cerebral tumor any place other than fields
(9)
When it is multiple, and a lesion with suspected recurrence of tumor develops independently than three places outside in fields or fields
(10)
In addition, the patients whom a study person in charge judged to be inadequate as subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Superiority of the sensitivity of C-11 methionine PETover that of F-18 FDG
- Secondary Outcome Measures
Name Time Method Efficacy: <br>(1) <br>Agreement between the histopathology result and C-11 methionine PET result and F-18 FDG <br>(2) <br>Positive-predictive value (PPV) of C-11 methionine PET <br>(3) <br>The number of cases that treatment strategy was changed from medical treatment to surgical or radiotherapy. <br>(4) <br>PET imaging agreement rate between readers of third party interpretation Committee <br>Safety: Adverse event