NCT07555769RecruitingPhase 1
Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 12 Oct 2026
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- Juan Luis Vásquez
- Diseases
- Bladder cancer
- NCT number
- NCT07555769
- EU CT number
- 2026-526388-39-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 12 Oct 2026 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible
Lab values
- 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)
Other
- Pregnancy (confirmed by a blood sample) or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.