UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029524 |
|---|---|
| Receipt number | 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 | 2021/10/15 12:34:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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 | Ukihide |
| Middle name | |
| Last name | Tateishi |
Organization
Medical Hospital Tokyo Medical and Dental University
Division name
Department of Diagnostic Radiology
Zip code
113-8510
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5311
ttisdrnm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Medical Hospital Tokyo Medical and Dental University
Division name
Department of Diagnostic Radiology
Zip code
113-8510
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5311
Homepage URL
tcymrad@tmd.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology,Medical Hospital Tokyo Medical and Dental University
Institute
Department
Personal name
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
Tokyo Medical and Dental University, institutional review borad
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4724
info.bec@tmd.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
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
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033567
