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

NCT07555769 | Not Yet Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 2026-526388-39-00
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Keywords

calcium electroporation; electroporation; transurethral electroporation; bladder tumors; urothelial tumor

Outcome Measures

Primary Outcomes (1)

• 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).

  From treatment to follow-up after 3 months

Secondary Outcomes (14)

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

  From treatment to 12 months follow-up

• Response rate of tumor

  From treatment to 12 months follow-up

• Local control of tumor

  From treatment to 12 months follow-up

• Tumor response to CaEP

  From treatment to 12 months follow-up

• Dissemination of tumor to other sites of the bladder

  From treatment to 12 months follow-up

Study Arms (1)

Intervention arm with participants treated with calcium electroporation

EXPERIMENTAL

Intervention arm with participants treated with calcium electroporation

Procedure: Calcium electroporation; Drug: Intratumoral calcium injection; Device: Transurethral electroporation

Interventions

Calcium electroporation PROCEDURE

Calcium electroporation involves injection of calcium gluconate into the urinary bladder tumor followed by short, electric pulses (electroporation) with the transurethral electrode

Intervention arm with participants treated with calcium electroporation

Intratumoral calcium injection DRUG

Intratumoral injection of calcium gluconate in the urinary bladder

Intervention arm with participants treated with calcium electroporation

Transurethral electroporation DEVICE

After injection of calcium into tumor, electroporation is applied using the transurethral electrode

Also known as: OpField electrode

Intervention arm with participants treated with calcium electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Juan Luis Vásquez: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Juan Luis Vásquez

CONTACT

0045 25603442; julv@regsj.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof, Chief Consultant, MD, PhD

Model Details: The study is a phase I, exploratory, single-arm safety study with 20 patients

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be available immediately following publication in supplementary material to anyone with access to the publication. Data is available as long as the publication is available.
• Access Criteria: The data will be available immediately following publication in supplementary material to anyone with access to the publication.