UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031205 |
|---|---|
| Receipt number | R000035334 |
| Scientific Title | A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma |
| Date of disclosure of the study information | 2018/03/21 |
| Last modified on | 2022/02/14 23:21:29 |
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Basic information
Public title
A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Acronym
efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Scientific Title
A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Scientific Title:Acronym
efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Region
| Japan |
Condition
Condition
Upper urinary tract urothelial carcinoma
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of pathologically positive patients who were photodynamically positive.
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
| Medicine |
Interventions/Control_1
Administration of ALA HCl 2-4 hours before ureterorenoscopy
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
Patients who will undergo ureterorenoscopy for
diagnosis of upper urinary tract urothelial carcinoma
Key exclusion criteria
Patients with allergy to ALA HCl or porphyrin, light hypersensitivity
Patients with administration of the drugs which are contraindicated contraindication with ALA HCl
Pregnant or lactating woman
Patients with severe underlying diseases such as cardiovascular event, liver disfunction, diabetes mellitus, and so on.
Patients who have been enrolled into another study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Katayama |
Organization
Okayama University Hospital
Division name
Urology
Zip code
7008558
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL
086-235-7287
skatayama18@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Katayama |
Organization
Okayama University Hospital
Division name
Urology
Zip code
7008558
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL
086-235-7287
Homepage URL
skatayama18@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
Tel
0862357287
mae6605@adm.okayama-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
| 2018 | Year | 03 | Month | 21 | Day |
Related information
URL releasing protocol
https://bmcurol.biomedcentral.com/articles/10.1186/s12894-021-00819-2
Publication of results
Published
Result
URL related to results and publications
https://bmcurol.biomedcentral.com/articles/10.1186/s12894-021-00819-2
Number of participants that the trial has enrolled
20
Results
Based on the results for these 18 patients, the sensitivity and specificity of ALA-PDD were calculated to be 80.0% and 33.3%, respectively, whereas for white light observation the respective values were 86.7% and 66.7% (Table 2). The PPV and NPV of ALA-PDD were 59.5% and 70.0%, respectively. The combined observation had the highest sensitivity at 72.5%, but the lowest specificity at 51.9%.
Results date posted
| 2022 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients that were enrolled in the study were adults who were suspected of having UT-UC and were undergoing URS. All patients were aware of the conditions associated with the disease, and provided informed consent to participate. All enrolled patients agreed to use contraception until 1 month after the administration of 5-ALA. Exclusion criteria were patients with porphyria, allergy to porphyrin or 5-ALA, hepatic dysfunction, use of drugs that induced photosensitivity, pregnancy, or severe underlying diseases such as cardiovascular diseases or infection.
Participant flow
20 mg/kg of 5-aminolevulinic acid hydrochloride (5-ALA HCl) was orally administered over 180 min before the scheduled insertion time for the ureteroscope. After oral administration of 5-ALA HCl, patients drank 250 mL of an L-arginine-intensive drink and 500 mL of fruit juice to maintain blood pressure. At the time of examination, normal observations using white light and ALA-PDD using visible blue light were carried out using a two-color LED light source. All endoscopic images were recorded.
After the procedures, Hematologic and biochemical examinations were performed on postoperative days (POD) 1 and 3 and the occurrence of adverse events was noted.
Adverse events
For adverse events, all patients took the first 50 mL of drug solution including 5-ALA HCl; however, two patients complained of nausea and one vomited 2 h after taking 5-ALA HCl. Other symptoms included elevated serum aminotransferase that required no additional treatment (Clavien-Dindo Grade I) in 6 patients and hypotension requiring vasopressors (Grade II) in one patient. No allergic episodes, cardiovascular complications or photosensitivity were observed in our study.
Outcome measures
The primary endpoint was the proportion of positive subjects and secondary endpoints were sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and adverse events for ALA-PDD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 21 | 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
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035334
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