Trial studying safety and effects for Bladder Tumors
Official title Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
ClinicalTrials.gov ID: NCT07555769
What this study is testing
What is Intratumoral calcium injection?
Intratumoral calcium injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for bladder tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
- Hypersensitivity to calcium gluconate or any of its excipients
- Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis...
See the full eligibility 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...
- 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
- 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
- Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)
The study team makes the final eligibility decision.
Where it is enrolling
- Roskilde, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Roskilde, Denmark. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.