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Efficacy of 5-aminolevulinic acid for Upper urinary tract carcinoma

The effect of 5-aminolevulinic acid to diagnose the upper urinary tract tumor with retrograde intra-renal ureteroscopy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051200004
Enrollment
20
Registered
2020-04-23
Start date
2020-03-25
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

Upper urinary tract urothelial carcinoma KeywordUpper urinary tract urothelial carcinoma, endourological surgery, 5-aminolevulinic acid, photodynamic diagnosis

Interventions

Medication
5-aminolevulinic acid, photodynamic diagnosis

Sponsors

Yoshida Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 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.

Exclusion criteria

Exclusion criteria: 1)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

Design outcomes

Primary

MeasureTime frame
Progression-free survival duration; progression is defined as radiographic progression, inability of endoscopic surgery, tumor up-grading

Secondary

MeasureTime frame
Duration of recurrence free survival, cancer-specific survival, and overall survival, safety

Contacts

Public ContactTakashi Yoshida

Kansai Medical University

yoshidtk@takii.kmu.ac.jp+81-72-804-0101

Outcome results

None listed

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