NIPH Clinical Trials Search

JRCT ID: jRCTs051200004

Registered date:23/04/2020

Efficacy of 5-aminolevulinic acid for Upper urinary tract carcinoma

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUpper urinary tract urothelial carcinoma
Date of first enrollment25/03/2020
Target sample size20
Countries of recruitment
Study typeInterventional


Primary OutcomeProgression-free survival duration; progression is defined as radiographic progression, inability of endoscopic surgery, tumor up-grading
Secondary OutcomeDuration of recurrence free survival, cancer-specific survival, and overall survival, safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Patients who are over 20 years old at the time of obtaining consent (regardless of gender) 2) Patients with confirmed pathological diagnosis and malignancy of cancer by ureteroscopy with biopsy 3) Patients who are planned to undergo endourological sugery for upper urinary tract carcinoma and who fit any of 1 to 4 below. 1. A case of locally localized cancer that has occurred in a solitary kidney or bilaterally 2. Patients who need renal function preservation and avoidance of dialysis for patients with renal dysfunction or poor PS 3. Cases with a healthy kidney on the contralateral side, a single tumor with a tumor diameter of 1 cm or less, diagnosed as low grade or low stage 4. Patients who refused radical radical nephroureterectomy. However, this is limited to cases where an alternative urinary endoscopic treatment is desired. 4) Those who have received sufficient explanations for participation in this study, and who have fully understood and have given their written consent. 5) Patients who have been notified of the disease name and condition, who have the ability to consent, and who have obtained document consent.
Exclude criteria1)Patients with porphyrine or porphyrine metabolites allergy 2)Patients with 5-aminolevulinic Acid allergy 3)Pregnancy 4)Patients taking concomitant contraindications: Drugs that may cause photosensitivity (Tetracycline antibiotics, Newquinolone antibiotics, Sulfonamides).patients eating food containing Hypericum perforatum (St. John's Wort) , Hypericin. 5)Patients who have been determined to be unsuitable as a subject by a physician

Related Information


Public contact
Name Takashi Yoshida
Address 2-3-1, Shin-machi, Hirakata-shi, Osaka Osaka Japan 573-1010
Telephone +81-72-804-0101
Affiliation Kansai Medical University
Scientific contact
Name Takashi Yoshida
Address 2-3-1, Shin-machi, Hirakata-shi, Osaka Osaka Japan 573-119
Telephone +81-72-804-0101
Affiliation Kansai Medical University Hospital