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JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00081

Registered date:30/01/2012

5-aminolevulinic acid mediated photodynamic diagnosis for urothelial cancer of the urinary bladder to detect the red fluorescent area.

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedurothelial cancer of the urinary bladder
Date of first enrollment13/02/2012
Target sample size60
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:5-ALA, Dose form:POWDER, Route of administration:ORAL, intended dose regimen:5-ALA dissolved in water is administered orally 3 hours (2 to 4 hours) prior to endoscopy . Control intervention1:Standard White Light Cystoscopy.

Outcome(s)

Primary OutcomeSensitivity. Timepoint:2-3 hours after 5-ALA oral administration.
Secondary OutcomeNegative Predictability, Specificity, Positive Predictability. Timepoint: 2-3 hours after 5-ALA oral administration.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximum<=84 YEARS
GenderBOTH
Include criteria1) Patients candidate for TURBT 2) Patients with ECOG Performance Status 0-1 3) Patients with written informed consent 4) Patient in well compliance with protocol
Exclude criteria1) Patient with poor controlled infection 2)Patient with severe complications e.g. malignant hypertension, severe cardiac failure congestive, severe hepatic failure, myocardial infarction within last three months, cirrhosis in terminal stage, diabetes mellitus poor control, severe pulmonary fibroses, active interstitial pneumonia, and so on. 3) Patients with current bone marrow transplantation 4) Patient with sever mental disorder 5) Patients in treatment with other tumors 6) Patients with any abnormal function in kidney, liver, blood, heart or lung 7) Patient with known allergy to 5-ALA or a similar compound 8) Patients who have received BCG or chemotherapy within six months prior to informed consent 9) Participation in other clinical studies with investigational drugs either concurrently or within the last three months prior to informed consent 10) Pregnant or breast-feeding

Related Information

Contact

public contact
Name Fumiaki Kobayashi
Address 4-1-12, Tsukiji, Chuo-ku, Tokyo, 104-0045
Telephone +81-3-6228-4835
E-mail
Affiliation CTD.Inc
scientific contact
Name Taro Shuin
Address Department of Urology,Kohasu, Oko, Nankoku, Kochi, 783-8505
Telephone +81-88-866-5811
E-mail
Affiliation Kochi Medical School Hospital