Efficacy of 5-aminolevulinic acid for Upper urinary tract carcinoma

JRCT ID: jRCTs051200004

Registered date:23/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Upper urinary tract urothelial carcinoma
• Date of first enrollment: 25/03/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Medication

Outcome(s)

• Primary Outcome: Progression-free survival duration; progression is defined as radiographic progression, inability of endoscopic surgery, tumor up-grading
• Secondary Outcome: Duration of recurrence free survival, cancer-specific survival, and overall survival, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Yoshida Takashi