Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

Sponsor
Photocure
Study ID
NCT05600322
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hexaminolevulinate Hydrochloride — DRUG
    Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
  • Richard Wolf Photodynamic Diagnostic Equipment (PDD) system — DEVICE
    Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.

Study Details

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

Key Dates

Start date
Nov 3, 2022
Status verified
Jun 2024
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023

Study Design

Enrollment
158 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Hexvix Blue light cystoscopy
    In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.

Primary Outcome Measure

Number of Patients With Histology-confirmed Lesions (Ta, T1, or CIS) Who Have at Least One Such Lesion Found by Hexvix Blue Light Cystoscopy But Not by White Light Cystoscopy. [ Time Frame: 1 day (At time of cystoscopy examination) ]

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