Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a pathological diagnosis of bladder cancer.
Patients scheduled for radical cystectomy, with at least one measurable tumor lesion ≥10 mm in diameter.
Age between 18 and 75 years.
Treatment-naïve patients who have not received any prior therapy for bladder cancer.
Disqualifiers
Presence of severe comorbidities, including but not limited to cardiac disease, severe hepatic or renal insufficiency, uncontrolled hypertension, or diabetes.
Active urinary tract infection or a functional bladder capacity of less than 200 mL.
History of other malignancies.
Pregnancy or lactation.
Trial design
Design model
Single group
Treatments tested in this trial
Plasma-Activated Saline Solution (PASS) Bladder Instillation
DrugThis 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Plasma-Activated Saline Solution (PASS) Bladder InstillationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-treatment) and Day 7 (post-treatment).Secondary outcomes
1
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).
Time frame
At the time of surgery (cystectomy), performed immediately following the 7-day intervention period.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: