Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer

Preliminary Clinical Study Evaluating the Therapeutic Response and Safety of Intravesical Perfusion With Plasma-Activated Saline Solution in Patients With Bladder Cancer

This preliminary clinical study evaluates the safety and initial efficacy of a novel therapy called Plasma-Activated Saline Solution (PASS) for bladder cancer patients. The study involves a one-week course of PASS administered via bladder infusion in five pre-surgical patients, using imaging and pathology analyses to assess tumor shrinkage and cancer cell death, while closely monitoring for any adverse reactions to explore the therapy's future potential.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder (Urothelial, Transitional Cell) Cancer
• Intervention / Treatment: Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation

Detailed Description

This study is a prospective, proof-of-concept clinical trial investigating a novel local therapy for bladder cancer. The intervention involves the use of Plasma-Activated Saline Solution (PASS), a liquid infused with reactive oxygen and nitrogen species (RONS) created by exposing standard saline to cold atmospheric plasma. The goal is to leverage the potential of these activated substances to selectively target and kill cancer cells while minimizing damage to healthy bladder tissue.

The study will enroll a small cohort of five adult patients with confirmed bladder cancer who are already scheduled for a radical cystectomy (surgical removal of the bladder). This design allows for a direct assessment of the treatment's effect on the tumor within a short, controlled timeframe before surgery. Participants will receive intravesical (into the bladder) instillations of PASS every other day for one week, with each instillation retained for approximately one hour.

The primary objectives are twofold. First, to evaluate the treatment's efficacy, researchers will quantitatively measure the reduction in tumor volume using MRI scans conducted before and after the 7-day treatment period. Additionally, the surgically removed bladder tissue will be analyzed in the laboratory using immunohistochemistry to look for biological evidence of cancer cell death (apoptosis). Second, the study will rigorously assess safety and tolerability. This includes monitoring for severe, procedure-related adverse events and systematically tracking patient-reported symptoms like urinary pain and urgency using standardized diaries and scales.

As an initial exploratory investigation, this study is not designed to prove definitive clinical efficacy but to gather crucial first-in-human data on the biological activity and safety profile of PASS. The findings will determine whether this innovative approach warrants further development in larger clinical trials. The study will be conducted under strict ethical guidelines with close safety monitoring and full informed consent from all participants.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: weiqiang jing, PhD; Phone Number: 86+053182166714; Email: jiangxin98@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a pathological diagnosis of bladder cancer.
2. Patients scheduled for radical cystectomy, with at least one measurable tumor lesion ≥10 mm in diameter.
3. Age between 18 and 75 years.
4. Treatment-naïve patients who have not received any prior therapy for bladder cancer.

Exclusion Criteria:

1. Presence of severe comorbidities, including but not limited to cardiac disease, severe hepatic or renal insufficiency, uncontrolled hypertension, or diabetes.
2. Active urinary tract infection or a functional bladder capacity of less than 200 mL.
3. History of other malignancies.
4. Pregnancy or lactation.
5. Poor compliance, assessed as unlikely to complete the trial per protocol requirements.
6. Any other condition deemed by the investigator to make the patient unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Plasma-Activated Saline Solution (PASS) Bladder Instillation; This arm involves the intravesical instillation of the experimental intervention, Plasma-Activated Saline Solution (PASS), where 200 mL of the solution is administered into the bladder via a catheter every other day for 7 days, with a 1-hour dwell time, to evaluate its local efficacy in inducing tumor cell death and assess safety and tolerability.

Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation; This intervention is distinguished by its unique mechanism of action, which utilizes physically-activated normal saline infused with reactive oxygen and nitrogen species (RONS) generated by non-thermal plasma, creating a potent yet transient cytotoxic solution that is administered locally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tumor Size	The reduction in tumor volume will be quantitatively assessed by comparing the product of the largest perpendicular diameters of the target tumor lesion measured on high-resolution magnetic resonance imaging (MRI) scans before and after the intervention.	Baseline (pre-treatment) and Day 7 (post-treatment).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Tumor Cells Undergoing Apoptosis	The biological effect on tumor cells will be evaluated through immunohistochemical analysis of biopsy specimens obtained during the post-treatment cystectomy, specifically measuring the percentage of tumor cells testing positive for TUNEL staining, which indicates programmed cell death (apoptosis).	At the time of surgery (cystectomy), performed immediately following the 7-day intervention period.

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: benkang shi, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cancer; bladder; plasma; Intravesical Perfusion
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Topical; Administration, Intravesical
• Other Study ID Numbers: bks05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No