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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027540
Receipt No. R000031462
Scientific Title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Date of disclosure of the study information 2017/05/31
Last modified on 2017/06/15

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Basic information
Public title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Acronym FLT-PET imaging as a predictor of hematologic toxicity
Scientific Title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Scientific Title:Acronym FLT-PET imaging as a predictor of hematologic toxicity
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Tools are lacking to assess the individual risk of severe hematologic toxicity from chemotherapy.
This study is performed to clarify the prognostic value of FLT-PET imaging for severe hematologic toxicity in patients who recieve systemic chemotherapy for advanced lung cancer.
Basic objectives2 Others
Basic objectives -Others To evaluate diagnostic relevancy of FLT-PET/MRI imaging.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between FLT uptake of the vertebral body and severe hematologic toxities during platinum doublet chemotherapy.
Key secondary outcomes 1, Relationship between FLT uptake of the vertebral body and severe non-hematologic toxities during platinum doublet chemotherapy.
2, Relationship between FLT uptake of the vertebral body and progression-free survival and overall survival.

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
Device,equipment
Interventions/Control_1 All patients undergo FLT-PET/MRI before initiation of systemic chemotherapy.
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) Patients with previously untreated advanced lung cancer
2) Patients who have indication of platinum-based doublet chemotherapy
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4) Written informed consent
Key exclusion criteria 1) Pregnant woman
2) Patients with metalic device in their body
3) Patients with claustrophobia
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Email umeda@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third department of internal medicine, Universtiy of Fukui
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 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 Open public recruiting
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 30 Day
Last modified on
2017 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031462

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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