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Innovative blue laser-5ALA-PDT: a new method to prevent postoperative tumor recurrence of bladder cancer

A prospective, multicenter, randomized, controlled clinical study of blue laser-mediated 5ALA-photodynamic therapy (PDT) to prevent tumor recurrence of high-risk non-muscle invasive bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063281
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-02
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Bladder cancer

Interventions

test group:BL-5ALA-PDT
Control group:None

Sponsors

the First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathological result was identified as high-risk NMIBC, satisfy any of the following terms: (1) T1 tumor; (2) G3 or high-grade urothelial cancer; (3) CIS; (4) multiple, recurrent and TaG1-2 or low diameter > 3cm); 2. EORTC score above 5; 3. Patients aged 18-80 years, agreed (or authorized) to participate in the clinical trial and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious systemic diseases (such as severe coagulation dysfunction, decompensation of important organ function) or chronic wasting diseases; 2. Patients have a history of other malignant tumors in the past five years; 3. Pregnant and lactating women; 4. Those who have received large surgery within 1 month before the selection; 5. Participants in other clinical trials; 6. Other conditions (such as mental disorders).

Design outcomes

Primary

MeasureTime frame
Tumor recurrence rate at 1 year after surgery;

Secondary

MeasureTime frame
complication;

Countries

China

Contacts

Public ContactHe Dalin

the First Affiliated Hospital of Xi'an Jiaotong University

hedl@xjtu.edu.cn+86 13991288221

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026