UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009826
Receipt number R000011510
Scientific Title Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia
Date of disclosure of the study information 2013/01/21
Last modified on 2023/07/31 12:44:14

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Basic information

Public title

Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia

Acronym

Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia

Scientific Title

Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia

Scientific Title:Acronym

Dual-time-point 18F-FDG PET Imaging for Predicting Treatment Response in Patients with Interstitial Pneumonia

Region

Japan


Condition

Condition

Interstitial pneumonia

Classification by specialty

Pneumology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify whether dual-time-point 18F-FDG PET imaging is useful to predict treatment response in patients with interstitial pneumonia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Progression free survival of pulmonary function tests after treatment initiation

Key secondary outcomes

Overall survival after treatment initiation


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

Other

Interventions/Control_1

Patients undergo Dual-time-point 18F-FDG PET within 1 month before treatment initiation and 1 month after treatment initiation. To evaluate short-term disease progression, patients undergo pulmonary function testing at least every 3 months for 1 year after treatment initiation.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible patients are men and women aged 18 years or older with a diagnosis of interstitial pneumonia.

Key exclusion criteria

Exclusion criteria;
1, Fasting serum glucose levels above 150 mg/dl.
2, Pregnant women.
3, Nursing women.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Umeda

Organization

Faculty of Medical Sciences, 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

Faculty of Medical Sciences, 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 or person

Institute

Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui

Institute

Department

Personal name



Funding Source

Organization

University of Fukui Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Biomedical Imaging Research Center, Faculty of Medical Sciences, Universtity of Fukui

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

福井大学医学部附属病院(福井県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

Completed

Date of protocol fixation

2012 Year 12 Month 18 Day

Date of IRB

2012 Year 12 Month 17 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 21 Day

Last modified on

2023 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011510


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name