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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1091220081

Enrollment

Registered

2012-01-30

Start date

2012-02-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urothelial cancer of the urinary bladder

Interventions

Intervention type:DRUG Name of intervention:5-ALA Dose form / Japanese Medical Device Nomenclature:POWDER Route of administration / Site of application:ORAL Dose per administration:10 or 20 mg mg/kg D

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 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

Exclusion criteria

Exclusion criteria: 1) 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

Design outcomes

Secondary

Measure	Time frame
Negative Predictability, Specificity, Positive Predictability	—

Primary

Measure	Time frame
Sensitivity	—

Countries

Japan

Contacts

Public ContactFumiaki Kobayashi

CTD.Inc

+81-3-6228-4835

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026