Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA

Официальное название

A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Upper Urinary Tract Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA

Обзор

This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.

Подробное описание

This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients undergoing ureteroscopic resection for suspected upper tract urothelial carcinoma (UTUC). 5-ALA is an FDA-approved oral agent used in glioma surgery to promote fluorescence of malignant tissue under blue light. This study will evaluate whether similar visualization can be achieved in the upper urinary tract to aid in the identification and resection of UTUC. Up to 10 participants will be enrolled. Safety, technical feasibility, and tumor detection outcomes will be measured.

Вмешательства

• Препарат 5-Aminolevulinic acid Hydrochloride (Gliolan®)
  Participants will receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to surgery. The goal is to evaluate the feasibility of using fluorescence cystoscopy with blue light to improve tumor detection and visualization during ureteroscopic resection of upper tract urothelial carcinoma.

Первичные конечные точки

• Detection of tumor fluorescence using 5-ALA under blue light [Срок оценки: Day of Surgery]

Вторичные конечные точки (2)

• Incidence and severity of adverse events following 5-ALA administration [Срок оценки: Up to 30 days post-procedure]
• Presence of residual tumor at follow-up ureteroscopy [Срок оценки: Up to 3 months post-procedure]

Критерии участия

Критерии включения

• Patients aged 18 or older undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor
• Able to provide informed consent
• Able to comply with study requirements

Критерии исключения

• Known porphyria or hypersensitivity to porphyrins
• Pregnant or breastfeeding women
• AST or ALT > 2x upper limit of normal within 30 days prior to surgery
• Participation in another investigational study within 30 days
• Known allergy or contraindication to 5-ALA or its components

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Henry Ford Hospital — Detroit

Публикации

• Taoka R, Matsuoka Y, Yamasaki M, Kani N, Honda T, Harada S, Tohi Y, Kato T, Okazoe H, Tsunemori H, Ueda N, Sugimoto M. Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer. Photodiagnosis Photodyn Ther. 2022 Jun;38:102838. doi: 10.1016/j.pdpdt.2022 PMID 35381368
• Watanabe K, Tamura K, Matsushita Y, Watanabe H, Motoyama D, Ito T, Sugiyama T, Otsuka A, Miyake H. Significance of 5-Aminolevulinic Acid-mediated Photodynamic Diagnosis Following Standard Transurethral Resection in Non-muscle Invasive Bladder Cancer. Cancer Diagn Progn. 2021 Jul 3;1(3):201-205. doi: 10.21873/cdp.10027. eCollection 2021 Jul-Aug. PMID 35399308
• Nakai Y, Inoue K, Tsuzuki T, Shimamoto T, Shuin T, Nagao K, Matsuyama H, Oyama M, Furuse H, Ozono S, Miyake M, Fujimoto K. Oral 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A multicenter phase III study. Int J Urol. 2018 Aug;25(8):723-729. doi: 10.1111/iju.13718. Epub 2018 Jul 12. PMID 29999205
• Yoshida T, Setsuda S, Ishizuka M, Inoue T, Kinoshita H, Matsuda T. Photodynamic Diagnosis with Oral 5-Aminolevulinic Acid for Upper Urinary Tract Carcinoma: A Prospective Clinical Trial. J Endourol. 2020 Apr;34(4):509-515. doi: 10.1089/end.2019.0725. Epub 2020 Mar 31. PMID 31964177
• Fukuhara H, Kurabayashi A, Furihata M, Setuda S, Takahashi K, Murakami K, Tanaka T, Inoue K. 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence ureterorenoscopy for urinary upper tract urothelial carcinoma approximately Preliminary prospective single centre trial approximately . Photodiagnosis Photodyn Ther. 2020 Mar;29:101617. doi: 10.1016/j.pdpdt.2019.101617. Epub 2019 Dec PMID 31857216

Идентификаторы

NCT: NCT06948552 · HFH-IRB17325 · IRB17325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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