UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of comparison between fluorescence diagnosis and pathology of mesothelioma
Acronym	Fluorescence diagnosis of mesothelioma
Scientific Title	Exploratory study of comparison between fluorescence diagnosis and pathology of mesothelioma
Scientific Title:Acronym	Fluorescence diagnosis of mesothelioma
Region	Japan

Condition
Condition	Mesothelioma Benign Asbestos Pleural Effusion
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the photodynamic diagnostic efficacy and safety of thoracoscopy for mesothelioma diagnosis using 5-aminolevulinic acid (SPP-00X) single oral administration
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the sensitivity of the mesothelioma detection per biopsy tissue between fluorescence diagnostics and white light diagnosis.
Key secondary outcomes	1.To compare successful diagnostic rate of mesothelioma between fluorescent diagnosis and historical control with white light diagnosis 2.To examine the pathological tissue in the biopsy specimen of the fluorescent diagnosis 3.To compare the ratio of tumor lesion area per biopsy tissue area between the fluorescence diagnosis and white light diagnosis. 4. To examine pathological findings of benign asbestos pleural effusion example. 5.To examine the safety of the fluorescence diagnosis of mesothelioma using 5-ALA.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Aminolevulinic acid 20mg/kg at the exam day, p.o.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Benign asbestos pleural effusion with a history of asbestos exposure Mesothelioma suspected by chest CT, FDG-PET or cytology of pleural effusion with a history of asbestos exposure
Key exclusion criteria	1. Cases of pregnancy or lactation 2. Patients with porphyria 3. Patients with chronic hepatitis, chronic renal failure 4. Cases cannot be obtained the consent of the study 5. Cases that have a clear inflammation findings 6. Patients with a history of drug allergy 7. Patients within consent before obtaining four weeks participating in other clinical trials. 8. Cases with inappropriate to join the study decided by the research investigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kitada
Organization	Asahikawa Medical University
Division name	Respiratory Center
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL	0166-69-3290
Email	k1111@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Onishi
Organization	Asahikawa Medical University
Division name	Respiratory Center
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL	0166-69-3290
Homepage URL
Email	k-onishi@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University Respiratory Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Okayama Rosaki Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa Medical University
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
Tel	0166-65-2111
Email	sho-kenkyu@jimu.asahikawa-med.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	2015 Year 12 Month 18 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	2015 Year 08 Month 27 Day
Date of IRB	2015 Year 10 Month 30 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2019 Year 03 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	2015 Year 12 Month 18 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023392