UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020266 |
|---|---|
| Receipt number | R000023392 |
| Scientific Title | Exploratory study of comparison between fluorescence diagnosis and pathology of mesothelioma |
| Date of disclosure of the study information | 2015/12/18 |
| Last modified on | 2019/12/24 14:21:32 |
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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
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
k-onishi@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Respiratory Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023392
