Not yet recruiting NCT07555769
Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcium electroporation, Intratumoral calcium injection, Transurethral electroporation.
- Who it may be relevant to
- Registry conditions: Bladder Tumors, Bladder Tumor, Urothelial Carcinoma (UC), Urothelial Carcinoma Bladder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial
Overview
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.
Interventions
- Procedure Calcium electroporation
Calcium electroporation involves injection of calcium gluconate into the urinary bladder tumor followed by short, electric pulses (electroporation) with the transurethral electrode - Drug Intratumoral calcium injection
Intratumoral injection of calcium gluconate in the urinary bladder - Device Transurethral electroporation
After injection of calcium into tumor, electroporation is applied using the transurethral electrode
Primary outcome measures
- Safety within 3 months post-treatment assessed by adverse and serious adverse events. [Time frame: From treatment to follow-up after 3 months]
Secondary outcome measures (12)
- Safety within 12 months post-treatment assessed by adverse and serious adverse events. [Time frame: From treatment to 12 months follow-up]
- Response rate of tumor [Time frame: From treatment to 12 months follow-up]
- Local control of tumor [Time frame: From treatment to 12 months follow-up]
- Tumor response to CaEP [Time frame: From treatment to 12 months follow-up]
- Dissemination of tumor to other sites of the bladder [Time frame: From treatment to 12 months follow-up]
- Metastasis of tumor to other sites in the body will be evaluated by CT scan [Time frame: From treatment to 12 months follow-up]
- Time to progression evaluated by the revised RECIST criteria on CT scan [Time frame: From treatment to 12 months follow-up]
- Progression-free survival rate evaluated by cystoscopy, biopsy and CT scan [Time frame: From treatment to 12 months follow-up]
- Evaluation of quality of life using EORTC-QLQ-C30 before treatment and at follow-up [Time frame: From treatment to 12 months follow-up]
- Evaluation of urinary symptoms registered in the ICIQ-FLUTS/ICIQ-MLUTS [Time frame: From treatment to 12 months follow-up]
- Evaluation of sexual matters registered in the ICIQ-FLUTSsex/ICIQ-MLUTSsex [Time frame: From treatment to 12 months follow-up]
- All-cause mortality and cancer related mortality within 12 months [Time frame: From treatment to 12 months follow-up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07555769 · 2026-526388-39-00 · 2026-526388-39-00