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Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients

NCT05547516 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-09-21

No results posted yet for this study

Summary

This project will conduct a large-sample, multi-center prospective clinical trial to further establish the safety and efficacy of BL-5ALA-PDT in preventing Non-Muscle Invasive Bladder Cancer (NMIBC) recurrence when compared to the usual postoperative perfusion chemotherapy regimen.

Conditions

  • Non-muscle-invasive Bladder Cancer

Interventions

DRUG

Standard infusion chemotherapy

standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.), dissolved in 50mL normal saline or glucose, intravesical infusion chemotherapy, retained for 60min. Perfusion can be performed within 24 hours after surgery, and then once a week for a total of 8 times, and then once a month until 12 months after surgery

PROCEDURE

BL - 5 ala PDT

BL - 5 ala PDT - plan: 5ALA 1.5g (Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd), dissolved in 50mL normal saline, was infused into the bladder for 2 hours before surgery and before each cystoscopy. Blue laser irradiation was performed under a flexible cystoscope at 30mW/cm2 for 21min. PDT was performed during the operation and at 3, 6, and 9 months after the operation.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Dalin He, Dr. · The First Affiliated Hospital of Xi 'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2022-09-13
Completion
2024-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547516 on ClinicalTrials.gov