UMIN-CTR Clinical Trial

Public title

Detection of recurrence after radiation therapy using C-11 methionine PET

Acronym

Detection of recurrence after radiation therapy using C-11 methionine PET

Scientific Title

Detection of recurrence after radiation therapy using C-11 methionine PET

Scientific Title:Acronym

Detection of recurrence after radiation therapy using C-11 methionine PET

Region

Japan

Condition

Primary or secoundary brain tumor, Tumor of the neighboring organ

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We evaluate the usefulness of C-11 methionine comparing with F-18 FDG. C-11 methionine will be prepared using a methionine synthesizer (C-MET100).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Superiority of the sensitivity of C-11 methionine PETover that of F-18 FDG

Key secondary outcomes

"Efficacy:
(1)
Agreement between the histopathology result and C-11 methionine PET result and F-18 FDG
(2)
Positive-predictive value (PPV) of C-11 methionine PET
(3)
The number of cases that treatment strategy was changed from medical treatment to surgical or radiotherapy.
(4)
PET imaging agreement rate between readers of third party interpretation Committee
Safety: Adverse event
"

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

PET

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

"(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
"

Key exclusion criteria

"(1)
The patients with a history of 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
"

Target sample size

99

Name of lead principal investigator

1st name
Middle name
Last name	Tohru Shiga

Organization

Hokkaido University Hospital

Division name

Depertment of Nuclear Medicine

Zip code

Address

N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638

TEL

011-706-5152

Email

tshiga@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Coordination Secretariat

Organization

Hokkaido University Graduate School of Medicine

Division name

Depertment of Nuclear Medicine

Zip code

Address

N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638

TEL

011-706-5152

Homepage URL

Email

tshiga@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

1.Osaka University Hospital
2.Fukushima Medical University Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大坂府）
福島県立医科大学附属病院（福島県）

Date of disclosure of the study information

2015

Year

01

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2014

Year

12

Month

25

Day

Date of IRB

2019

Year

03

Month

07

Day

Anticipated trial start date

2015

Year

01

Month

12

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

06

Day

Last modified on

2019

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018672