Calcium electroporation for bladder tumors in adults who can’t have standard treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial investigates intravesical calcium electroporation using a new transurethral electrode in adults with urothelial bladder tumors. The primary goal is to assess safety, while secondary goals look at preliminary signals of efficacy in patients for whom standard treatments aren’t suitable. Eligible participants may receive simultaneous systemic therapy, and the procedure involves intratumoral calcium delivery followed by electroporation. The study design includes careful safety monitoring and predefined criteria for tolerability and early response. Enrollment targets patients with high-burden non-muscle-invasive bladder tumors and those unfit for cystectomy or radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Disease where other treatments are considered unsuitable or have been declined by the patient
* The patient may receive simultaneous systemic treatment
* Selected high-burden non-muscle-invasive bladder tumors after MDT assessment
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
* Life expectancy of ≥ 3 months
* Patients must be deemed able to tolerate general anesthesia
* Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization
* Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines
* Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed
* Hematology

  * Thrombocytes ≥ 50 billion/L
  * International normalized ratio (INR) ≤ 1.5. Correction is allowed

Exclusion Criteria:

* 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
* Contraindications to treatment with calcium gluconate as described:

  * Hypersensitivity to calcium gluconate or any of its excipients
  * Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)

Where it's running

• Department of Urology, Zealand University Hospital - Copenhagen University Hospital
  Roskilde, Denmark Recruiting

Study contacts

• Study coordinator: Juan Luis Vásquez
• Email: julv@regsj.dk
• Phone: 0045 25603442

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.