UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002048
Receipt number R000002265
Scientific Title Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Date of disclosure of the study information 2009/06/06
Last modified on 2019/04/01 12:42:36

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Basic information

Public title

Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT

Acronym

Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.

Scientific Title

Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT

Scientific Title:Acronym

Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.

Region

Japan


Condition

Condition

Malignant tumor

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology
Neurology Radiology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate diagnostic efficacy of 11C- methionine PET/CT for malignant tumors of limited FDG PET efficacy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concordance with histological diagnosis of surgical specimen. Concordance of clinical stage with postsurgical stage.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine Maneuver

Interventions/Control_1

11C-methionine PET/CT

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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following conditions.1. Malignant tumor of either brain, mediastinum, lung, or urinary tract2. Surgery is planned 3. Medically fits for surgery4. Written informed consent obtained.

Key exclusion criteria

Patients who meet at least one of the following conditions.1. Malignant tumor of neiother brain, mediastinum, lung, nor urinary tract.2. Medically unfit for surgery or suegery not planned.3. Informed consent not given.

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Ichiei
Middle name
Last name Kuji

Organization

Saitama Medical University

Division name

Saitama International Medical Center

Zip code

350-1298

Address

Yamane 1397-1, Hidaka-shi, Saitama

TEL

042-984-4147

Email

kuji@saitama-med.ac.jp


Public contact

Name of contact person

1st name Ichiei
Middle name
Last name Kuji

Organization

Saitama Medical University International Medical Center

Division name

Clinical Trial Support Center

Zip code

350-1298

Address

Yamane 1397-1, Hidaka-shi, Saitama

TEL

042-984-4523

Homepage URL


Email

chikens@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Radiology
Saitama Medical Center
Saitama Medical University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University International Medical Center IRB

Address

Yamane 1397-1, Hidaka-shi, Saitama

Tel

042-984-4523

Email

chikens@saitama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

埼玉医科大学国際医療センター
埼玉医科大学総合医療センター


Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

1563

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2007 Year 07 Month 09 Day

Date of IRB

2007 Year 07 Month 18 Day

Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2009 Year 06 Month 05 Day

Last modified on

2019 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002265


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name