UMIN-CTR Clinical Trial

Basic information
Public title	Analyses of lung, airways, and pleural lesions using probe-based confocal laser endomicroscopy
Acronym	pCLE imaging of lung, airways and pleural lesions
Scientific Title	Analyses of lung, airways, and pleural lesions using probe-based confocal laser endomicroscopy
Scientific Title:Acronym	pCLE imaging of lung, airways and pleural lesions
Region	Japan

Condition
Condition	Pulmonary and pleural diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to collect real time microscopic imaging data of pulmonary and pleural lesions using pCLE via respiratory endoscopy prospectively. This study also aims at establishment of standard pCLE images of various pulmonary diseases in comparison with chest CT findings and optical microscopic findings.
Basic objectives2	Others
Basic objectives -Others	To analyze pCLE images of various thoracic diseases
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To analyze pCLE images of various thoracic diseases
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	Device,equipment
Interventions/Control_1	When performing observation or biopsy via respiratory endoscopy, we would observe and record microstructure images of the lesions via probe-based confocal microscopy (Cellvizio - Alveoflex; Mauna Kea Technologies, Paris, France).
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 with pulmonary or pleural lesions who undergo respiratory endoscopy Patients who voluntarily provide written informed consent
Key exclusion criteria	Patients with severe respiratory insufficiency who are thought to be inadequate to extend examination time by additional procedures related to pCLE Patients who are considered ineligible for the study by the attending physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Imaizumi
Organization	Fujita Health University
Division name	Department of Respiratory Medicine
Zip code	4701192
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake
TEL	0562-93-9241
Email	jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Imaizumi
Organization	Fujita Health University
Division name	Department of Respiratory Medicine
Zip code	4701192
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi, Japan
TEL	0562-93-9241
Homepage URL
Email	jeanluc@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health 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	Administrative office of research promotion and support, Fujita Health University
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi Japan
Tel	0562-93-2865
Email	f-irb@fujita-hu.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	藤田保健衛生大学病院　（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 15 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	2015 Year 07 Month 06 Day
Date of IRB	2018 Year 05 Month 29 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2025 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 01 Day
Last modified on	2021 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021435