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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031270
Receipt No. R000035658
Scientific Title Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Date of disclosure of the study information 2018/02/15
Last modified on 2018/02/16

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Basic information
Public title Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Acronym Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Scientific Title Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Scientific Title:Acronym Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Region
Japan

Condition
Condition Benign or malignant pulmonary lesions
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions will be investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of reaching the lesion and rate of cases for which cone beam CT was effective
Key secondary outcomes 1. DirectPath
Regions and the bronchial generation order for which virtual images are automatically prepared
Regions and the bronchial generation order for which manual imaging is added
2. Bronchoscopy
Consistency with virtual images
Region and the bronchial generation order allowing insertion
Region and the bronchial generation order observed
3. EBUS
Findings: within, adjacent to, invisible
4. Cone beam CT
Findings: centered, inside, and outside
Number of acquisitions
5. Diagnostic yield
Diagnostic yield (histological diagnostic yield and overall diagnostic yield combining culture, cytology, and histological diagnosis)
Diagnostic yield by the final diagnosis (benign, malignant)
Diagnostic yield by the lesion size (larger or smaller than 2 cm)
Diagnostic yield by the distance of the lesion from the pulmonary hilum (1/3 intermediate, 1/3 lateral)
Diagnostic yield by the pulmonary lobe
Diagnostic yield by the presence or absence of involved bronchus
Diagnostic yield by the character of the lesion (solid, ground glass nodule)
Diagnostic yield by cone beam CT findings
6. Examination and fluoroscopy time and X-ray exposure
Bronchoscopic examination time
Total fluoroscopy time
Cumulative dose area product (DAP) (fluoroscopy, acquisition)
Cumulative Frontal Air Kerma
7. Safety
Complications

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 Cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy
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) A 3-cm or smaller peripheral pulmonary lesion is present on chest CT and bronchoscopic examination is necessary to diagnose it or decide on a treatment strategy.
2) The bronchus or pulmonary artery involved in the lesion can be confirmed on chest CT.
3) Age of 20 years old or older
4) SpO2 of 90% or higher
5) Obtainment of written consent to participation in the study directly from the patients.
Key exclusion criteria 1) A lesion is considered present on the central side of the subsegmental bronchus on bronchoscopy.
2) It is clear that the lesion is benign on imaging such as CT.
3) The presence of serious complication which may interfere with examination
4) Oral medication with anticoagulant and antiplatelet agent unable to be discontinued
5) Pregnancy
6) The presence of another complication which may seriously interfere with execution of the examination.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Asano
Organization Gifu Prefectural General Medical Center
Division name Department of Pulmonary Medicine
Zip code
Address 4-6-1, Noishiki, Gifu, Japan
TEL 058-246-1111
Email asano-fm@ceres.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Asano
Organization Gifu Prefectural General Medical Center
Division name Department of Pulmonary Medicine
Zip code
Address 4-6-1, Noishiki, Gifu, Japan
TEL 058-246-1111
Homepage URL
Email asano-fm@ceres.ocn.ne.jp

Sponsor
Institute Gifu Prefectural General Medical Center
Institute
Department

Funding Source
Organization Self-funding
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
2018 Year 02 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
2018 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 15 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
2018 Year 02 Month 13 Day
Last modified on
2018 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035658

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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