Calcium electroporation delivered through the urethra for bladder cancer
Tests calcium electroporation for safety in adults with bladder tumors.
Plain-language title generated from the registry record
Registry title: Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
Key facts
- Where
- Roskilde, DenmarkSee the site
- Phase
- Phase 1
Where in Denmark
- Region SjaellandRoskilde, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Juan Luis Vásquez
- Trial code
- NCT07555769EU 2026-526388-39-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER 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.
Inclusion: 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: Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible; Allergy to calcium gluconate or any of its excipients; 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); Pregnancy (confirmed by a blood sample) or lactation.