A Phase 1 interventional study of Calcium electroporation and Intratumoral calcium injection in Bladder Tumors, Bladder Tumor and Urothelial Carcinoma (UC), sponsored by Juan Luis Vásquez. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Juan Luis Vásquez · Phase 1, Interventional, and Other
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →This is the only study on the registry with Juan Luis Vásquez as lead sponsor.
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Hematology
Exclusion Criteria:
Contraindications to treatment with calcium gluconate as described:
Intervention arm with participants treated with calcium electroporation
Procedure: Calcium electroporation · Drug: Intratumoral calcium injection · Device: Transurethral electroporation
Calcium electroporation involves injection of calcium gluconate into the urinary bladder tumor followed by short, electric pulses (electroporation) with the transurethral electrode
Intratumoral injection of calcium gluconate in the urinary bladder
After injection of calcium into tumor, electroporation is applied using the transurethral electrode
Also known as: OpField electrode
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
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
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
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
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
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
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
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.
Time frame: From treatment to 12 months follow-up
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.
Time frame: From treatment to 12 months follow-up
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.
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
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.
Time frame: From treatment to 3 months follow-up
Concentration of calcium in a blood sample before injection of calcium gluconate 30 minutes and 2 hours after injection
Time frame: Before treatment (Baseline), 30 minutes after injection of calcium gluconate, and 2 hours after injection of calcium gluconate
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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