Clinical trial · Interventional
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
NCT07555769CI-TRIAL-00109723CALCIFERnot yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
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 Tumors | Bladder Neoplasm | ALIAS | 0.90 |
| Urothelial Carcinoma Bladder | Transitional Cell Carcinoma | PROBABILISTIC | 0.70 |
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium electroporation | Procedure | — | UNRESOLVED |
| Intratumoral calcium injection | Drug | — | UNRESOLVED |
| Transurethral electroporation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm with participants treated with calcium electroporation
- description
- Intervention arm with participants treated with calcium electroporation
- interventionNames
- Procedure: Calcium electroporation
- Drug: Intratumoral calcium injection
- Device: Transurethral electroporation
Primary outcomes (1)
- measure
- Safety within 3 months post-treatment assessed by adverse and serious adverse events.
- timeFrame
- From treatment to follow-up after 3 months
- description
- Safety within 3 months post-treatment assessed by adverse and serious adverse events (CTCAE ver. 6.0).
Secondary outcomes (14)
- measure
- Safety within 12 months post-treatment assessed by adverse and serious adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.