UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059340 |
|---|---|
| Receipt number | R000067865 |
| Scientific Title | Portable Conebeam CT Guided Bronchoscopy for Peripheral Pulmonary Lesions: A Pilot Study |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 16:52:00 |
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Basic information
Public title
Portable Conebeam CT Guided Bronchoscopy for Peripheral Pulmonary Lesions: A Pilot Study
Acronym
PORT-CBCT BRONC
Scientific Title
Portable Conebeam CT Guided Bronchoscopy for Peripheral Pulmonary Lesions: A Pilot Study
Scientific Title:Acronym
PORT-CBCT BRONC
Region
| Japan |
Condition
Condition
peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility of radial EBUS bronchoscopy combined with portable cone-beam CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tool-in-lesion confirmation rate by cone-beam CT
Key secondary outcomes
Diagnostic image quality achievement rate
Artifact score
Lesion discernibility score
Bronchial visualization rate
Examination-related time, compliance with breathing instructions
Complications (bleeding, pneumothorax, hypoxia, sedation-related events)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
During radial endobronchial ultrasound (EBUS) bronchoscopy for peripheral pulmonary lesions, a portable cone-beam CT system (mobile C-arm, Cios Spin; Siemens Healthcare) is used to confirm the position of the lesion and biopsy tool. One scan is performed, lasting approximately 30 seconds. Reconstructed images are reviewed immediately, and bronchoscopy is then continued as usual.
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
Adult patients (20 years old or older) scheduled to undergo bronchoscopy at Shimane University Hospital
Patients with a peripheral pulmonary lesion on imaging for which radial endobronchial ultrasound (EBUS) guided biopsy is clinically indicated
Patients who have received a full explanation of the study and provided written informed consent
Key exclusion criteria
Patients deemed inappropriate for participation due to radiation exposure considerations
Patients judged by the attending physician or bronchoscopist to be unsuitable for inclusion in this study
Patients found to be ineligible after consent has been obtained
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University Hospital
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2581
takamasa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University Hospital
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2581
Homepage URL
takamasa@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-sourced
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Shimane University Hospital
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067865
