Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial

Phase 1Not Yet RecruitingNCT07555769

Juan Luis Vásquez20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bladder Tumors Bladder Tumor Urothelial Carcinoma (UC)Urothelial Carcinoma Bladder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Safety within 3 months post-treatment assessed by adverse and serious adverse events.

Safety within 3 months post-treatment assessed by adverse and serious adverse events (CTCAE ver. 6.0).

Time frame: From treatment to follow-up after 3 months

Secondary Outcomes

Safety within 12 months post-treatment assessed by adverse and serious adverse events.

Safety within 12 months post-treatment assessed by adverse and serious adverse events (CTCAE ver. 6.0).