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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029524
Receipt No. R000033567
Scientific Title study on [F-18] FDG and [F-18] FLT in the assessment of malignant tumors
Date of disclosure of the study information 2019/04/01
Last modified on 2017/10/12

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Basic information
Public title study on [F-18] FDG and [F-18] FLT in the assessment of malignant tumors
Acronym study on [F-18] FDG and [F-18 FLT in the assessment of malignant tumors
Scientific Title study on [F-18] FDG and [F-18] FLT in the assessment of malignant tumors
Scientific Title:Acronym study on [F-18] FDG and [F-18 FLT in the assessment of malignant tumors
Region
Japan

Condition
Condition malignant tumors
Classification by specialty
Hematology and clinical oncology Obsterics and gynecology Oto-rhino-laryngology
Orthopedics Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy of [F-18] FLT (3'-Deoxy-3'-[F-18]fluorothymidine) PET/CT and establish the diagnostic system with [F-18] FLT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to show improved detectability of primary malignant tumors and their metastases or reccurrences, and the efficacy in the assessment of treatment response and prognosis using [F-18] FLT PET/CT.
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
Interventions/Control_1 FLT-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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. [F-18] FDG PET/CT is covered by insurance
2. patients who are 20 years of age or over
3. written informed consent has been obtained
Key exclusion criteria 1. patients with blood sugar level over 200mg/dl when they take [F-18] FDG PET/CT
2. patients who are pregnant or have high possibility of pregnancy
3. patients who are unable to give an appropriate consent in terms of mental and legal point of view
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ukihide Tateishi
Organization Medical Hospital Tokyo Medical and Dental University
Division name Department of Diagnostic Radiology
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL 03-5803-5311
Email ttisdrnm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Tsuchiya
Organization Medical Hospital Tokyo Medical and Dental University
Division name Department of Diagnostic Radiology
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL 03-5803-5311
Homepage URL
Email tcymrad@tmd.ac.jp

Sponsor
Institute Department of Diagnostic Radiology,Medical Hospital Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Department of Diagnostic Radiology,Medical Hospital Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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
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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information various parameters on PET/CT, progression free survival, overall survival.

Management information
Registered date
2017 Year 10 Month 12 Day
Last modified on
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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