Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07019220

Chemoablation for Low-Grade Bladder Cancer

Led by Ekaterina Laukhtina · Updated on 2025-06-13

47

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.

CONDITIONS

Official Title

Chemoablation for Low-Grade Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 18 years or older
  • Histologically confirmed diagnosis of recurrent or primary Ta low-grade bladder cancer within 8 weeks before screening
  • Largest tumor diameter of 15 mm or less on cystoscopy
  • Five or fewer bladder lesions
  • Cystoscopy with bladder diagram, including tumor number, site, size, and appearance, with photo documentation
  • Recurrence limited to Ta low-grade non-muscle invasive bladder cancer (low or intermediate European Association of Urology risk)
  • Non-muscle invasive bladder cancer requiring transurethral resection of bladder tumors (TURBT)
  • Negative urine cytology for high-grade disease within 8 weeks before screening
  • No lymph node or distant metastasis
  • Use of effective contraception during the study and for at least 6 months after treatment for male and female patients
  • Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Tumors suspected to be high-grade
  • Positive high-grade cytology
  • Tumor diameter greater than 15 mm
  • More than 5 bladder lesions
  • Any intravesical therapy within the past year
  • History of high-grade non-muscle invasive bladder cancer within the last 3 years
  • Past or current muscle invasive bladder cancer or metastatic urothelial carcinoma
  • History of upper tract urothelial carcinoma
  • Clinically significant urethral stricture preventing catheter passage
  • History of neurogenic bladder, active urinary retention, or conditions prohibiting normal voiding
  • Active urinary tract infection not resolved prior to biopsy or treatment
  • Refusal to participate
  • Known positive HIV test
  • Pregnant or breastfeeding females
  • Female patients of childbearing potential not using adequate contraception

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Urology, Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

E

Ekaterina Laukhtina Dr., Medical Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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