UMIN-CTR Clinical Trial

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
Email	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
Email	skatayama18@gmail.com

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035334