Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuan Luis Vásquez
About this trial
This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.
Eligibility criteria
Qualifiers
Age ≥ 18 years and able to understand participant information and give informed consent
Histologically verified urothelial bladder tumor
Unfit for cystectomy and/or radiotherapy
Patients with recurrence after radiotherapy unfit for salvage cystectomy
Disqualifiers
Pregnancy (confirmed by a blood sample) or lactation
Allergy to calcium gluconate or any of its excipients
Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible
Hypersensitivity to calcium gluconate or any of its excipients
Trial design
Treatments tested in this trial
- Calcium electroporation
- Intratumoral calcium injection
- Transurethral electroporation
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Juan Luis Vásquez
Lead sponsor
Zealand University Hospital
Sponsor institution
Source ClinicalTrials.gov