Clinical trial · Interventional

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

NCT07272603CI-TRIAL-00098670not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder (Urothelial, Transitional Cell) Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Plasma-Activated Saline Solution (PASS) Bladder Instillation	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Plasma-Activated Saline Solution (PASS) Bladder Instillation
description
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.
interventionNames
1. Drug: Plasma-Activated Saline Solution (PASS) Bladder Instillation

Primary outcomes (1)

measure
Change in Tumor Size
timeFrame
Baseline (pre-treatment) and Day 7 (post-treatment).
description
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.

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.