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Bladder TumorsPhase 1CALCIFERNCT07555769

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

A Phase 1 study testing Calcium electroporation, Intratumoral calcium injection and Transurethral electroporation in people with Bladder Tumors and Bladder Tumor, run by Juan Luis Vásquez at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Calcium electroporation, Intratumoral calcium injection and Transurethral electroporation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
12 Oct 2026to 1 Apr 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juan Luis Vásquez contact

0045 25603442

julv@regsj.dk

Denmark1 site, 1 recruiting

  • Department of Urology, Zealand University Hospital - Copenhagen University Hospital

    Roskilde, 4000

    Recruiting

Other trials in Denmark

About this study

Official title: Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER 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.

Being tested
Calcium electroporation, Intratumoral calcium injection, Transurethral electroporation
Keywords
calcium electroporation, electroporation, transurethral electroporation, bladder tumors, urothelial tumor
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcium electroporationProcedure or 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 injectionDrug

    Intratumoral injection of calcium gluconate in the urinary bladder

  • Transurethral electroporationDevice

    Also called OpField electrode

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

Study groups in NCT07555769
Study groupRoleWhat they receive
Intervention arm with participants treated with calcium electroporationExperimentalIntervention arm with participants treated with calcium electroporation
Receives: Procedure: Calcium electroporation; Drug: Intratumoral calcium injection; Device: Transurethral electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From treatment to follow-up after 3 months

Secondary outcomes (14)

  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).

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: From treatment to 12 months follow-up

  5. Dissemination of tumor to other sites of the bladder

    Dissemination of tumor to other sites of the bladder will be evaluated by visualization by cystoscopy and biopsy

    Measured: From treatment to 12 months follow-up

  6. Metastasis of tumor to other sites in the body will be evaluated by CT scan

    Measured: From treatment to 12 months follow-up

  7. Time to progression evaluated by the revised RECIST criteria on CT scan

    Measured: From treatment to 12 months follow-up

  8. Progression-free survival rate evaluated by cystoscopy, biopsy and CT scan

    Measured: From treatment to 12 months follow-up

  9. Evaluation of quality of life using EORTC-QLQ-C30 before treatment and at follow-up

    Quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-C30). The questionnaire consists of three scales, and each scale is scored from 0 to 100. Higher scores indicate higher level of function on the the functional scale and higher quality of life on the global health scale, but higher level of symptomatology on the symptom scale.

    Measured: From treatment to 12 months follow-up

  10. Evaluation of urinary symptoms registered in the ICIQ-FLUTS/ICIQ-MLUTS

    Urinary symptoms registered using the International Consultation on Incontinence Questionnaire Female/Male Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS (0-48 points)/ICIQ-MLUTS (0-44 points). Higher level of points indicate higher level of symptoms.

    Measured: From treatment to 12 months follow-up

  11. Evaluation of sexual matters registered in the ICIQ-FLUTSsex/ICIQ-MLUTSsex

    Evaluation of sexual matters using the International Consultation on Incontinence Questionnaire Female/Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex (0-14 points)/ICIQ-MLUTSsex (0-12 points)). Greater values indicating increasing problems with sexual matters.

    Measured: From treatment to 12 months follow-up

  12. All-cause mortality and cancer related mortality within 12 months

    Measured: From treatment to 12 months follow-up

  13. Experiences and opinions of up to ten of the patients that participate in the qualitative interviews

    A subset of up to 10 patients will participate in the qualitative interviews at 3 months.

    Measured: From treatment to 3 months follow-up

  14. Concentration of calcium in a blood sample before injection of calcium gluconate 30 minutes and 2 hours after injection

    Measured: Before treatment (Baseline), 30 minutes after injection of calcium gluconate, and 2 hours after injection of calcium gluconate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start12 Oct 2026
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion1 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
The study is a phase I, exploratory, single-arm safety study with 20 patients
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555769
Sponsor's protocol ID
2026-526388-39-00
Other IDs
2026-526388-39-00
Acronym
CALCIFER
Status last verified
Oct 2026
First submitted
14 Apr 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data will be available after deidentification. Furthermore, the study protocol with statistical analysis plan will also be available. The data will be available immediately following publication in supplementary material to anyone with access to the publication. Data can be used for any purposes. Data is available as long as the publication is available.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Calcium electroporation, Intratumoral calcium injection and Transurethral electroporation in people with Bladder Tumors and Bladder Tumor, run by Juan Luis Vásquez at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juan Luis Vásquez (0045 25603442, julv@regsj.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety within 3 months post-treatment assessed by adverse and serious adverse events. (time frame: From treatment to follow-up after 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07555769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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