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

ConditionsBladder TumorsBladder TumorUrothelial Carcinoma (UC)Urothelial Carcinoma Bladder
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuan Luis Vásquez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Hypersensitivity to calcium gluconate or any of its excipients

Trial design

Design model

Single group

Treatments tested in this trial

  • Calcium electroporation

    Procedure/Surgery

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

  • Intratumoral calcium injection

    Drug

    Intratumoral injection of calcium gluconate in the urinary bladder

  • Transurethral electroporation

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention arm with participants treated with calcium electroporationExperimental treatment 3 interventions

Trial outcomes

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).

Time frame
From treatment to follow-up after 3 months

Secondary outcomes

1

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).

Time frame
From treatment to 12 months follow-up
2

Response rate of tumor

Response rate of tumor will be evaluated by visualization of the treated area with cystoscopy and biopsies of tumor or tumor site in case of remission. Using an adaptation of the revised RECIST ver. 1.1 criteria the response to treatment will be evaluated

Time frame
From treatment to 12 months follow-up
3

Local control of tumor

Local control of tumor will be evaluated by visualization of the treated area with cystoscopy and biopsies of tumor or tumor site in case of remission. Using an adaptation of the revised RECIST ver. 1.1 criteria the response to treatment will be evaluated

Time frame
From treatment to 12 months follow-up
4

Tumor response to CaEP

A biopsy at every follow-up will be histologically examined for presence of malignancy and immune cell infiltration (hematoxylin and eosin (H\&E) stain)

Time frame
From treatment to 12 months follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juan Luis Vásquez

Lead sponsor

Zealand University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: