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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526388-39-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm with participants treated with calcium electroporation | Experimental | Intervention arm with participants treated with calcium electroporation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From treatment to 12 months follow-up |
| Response rate of tumor |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Luis Vásquez | Contact | 0045 25603442 | julv@regsj.dk |
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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.
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.
The data will be available immediately following publication in supplementary material to anyone with access to the publication.
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The study is a phase I, exploratory, single-arm safety study with 20 patients
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| Intratumoral calcium injection | Drug | Intratumoral injection of calcium gluconate in the urinary bladder |
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| Transurethral electroporation | Device | After injection of calcium into tumor, electroporation is applied using the transurethral electrode |
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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 |
| 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 | 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) | 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 | From treatment to 12 months follow-up |
| Metastasis of tumor to other sites in the body will be evaluated by CT scan | From treatment to 12 months follow-up |
| Time to progression evaluated by the revised RECIST criteria on CT scan | From treatment to 12 months follow-up |
| Progression-free survival rate evaluated by cystoscopy, biopsy and CT scan | 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. | 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. | 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. | From treatment to 12 months follow-up |
| All-cause mortality and cancer related mortality within 12 months | 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. | 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 | Before treatment (Baseline), 30 minutes after injection of calcium gluconate, and 2 hours after injection of calcium gluconate |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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