To compare the recurrence rate of tumor at 12 months following IMAGE1 S* assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B) in patients with primary or recurrent non-muscle-invasive urothelial bladder cancer (NMIBC Ta/T1/CIS…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of the proportions of Arm A and Arm B subjects that have a
histologically confirmed recurrence found at either three months, one year and
three years after TURB.
Secondary outcome
Peri-operative morbidity (30 days) assessed by the Clavien-Dindo score
Proportion of re-TUR (defined as within 3 months of initial TURB: this can be a
planned TURBT because of resection of high risk tumor, or because of recurrent
tumor confirmed at cystoscopy at three months)
Baseline characteristics of the patients, such as age or BMI
Comorbidities, such as Diabetes Mellitus or cardiovascular disease
Risk factors, such as smoking and use of anticoagulation
When appropriate: information on previous (adjuvant) treatment, such as type
and date of most recent treatment and re-TURs
Background summary
Diagnostics of urothelial cancer (UC) of the bladder is usually performed by
the visual approach including the need for biopsies or transurethral resection
of the bladder (TURB). Most tumors can be identified by White Light (WL)
cystoscopy. However, especially Carcinoma in situ (CIS) is difficult to
identify using this procedure. Non-identified tumors can later appear as
recurrence, some of which becoming invasive. This demonstrates the need for a
procedure that more accurately detects bladder tumors. Since a more accurate
detection of tumors leads to more targeted treatment and more complete
resection, the rate of recurrence may decrease with such procedures.
KARL STORZ has developed a new technique that is now ready for clinical
evaluation. With the IMAGE1 S* System, no endoscopic filter is needed to
enhance the image in order to gain more clarity. IMAGE1 S* is based on a new
software platform, which uses the different light wavelengths to produce images
with different contrast specifications. IMAGE1 S* offers a technique which
could be useful in bladder cancer treatment, since clearer images are likely to
result in reducing the numbers of tumors that are missed compared with the gold
standard White Light Imaging (WLI). Additionally, once the tumor is detected,
IMAGE1 S* images may help find the demarcation between tumor and healthy
tissue, resulting in more complete resection of the tumor(s). The recurrence
rate is expected to be decreased with the use of IMAGE1 S* by obtaining a
more complete resection, meaning the patient will need less invasive diagnostic
and surgical visits.
Study objective
To compare the recurrence rate of tumor at 12 months following IMAGE1 S*
assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B) in
patients with primary or recurrent non-muscle-invasive urothelial bladder
cancer (NMIBC Ta/T1/CIS).
Study design
This study is a multicenter randomized controlled trial in which the recurrence
rates of cancer between IMAGE1 S* assisted and WLI assisted TURB are
compared. Randomization is stratified by tumor multiplicity (single or
multiple), tumor status (primary or recurrent) and macroscopic findings
(papillary or flat, where CIS is scored as flat lesion). Patients randomized
into the experimental arm (Arm A) will undergo IMAGE1 S* and WLI assisted
TURB, whereas the patients in the control arm (Arm B) will undergo WLI only
assisted TURB. WLI is chosen as control, since it is considered the gold
standard for detecting bladder tumors. Short and long term follow up will be
recorded in order to evaluate the health gains for patients over a longer
period.
Each participating center must submit this protocol to their local MEC and each
participating center is responsible for the insurance of their patients. Data
from all participating centers will be collected through electronic Case Report
Forms, with use of an online Data Management System.
Intervention
IMAGE1 S* + WL assisted TURB (experimental arm) vs WL only assisted TURB
(control arm)
Study burden and risks
The risks patients are subject to in this trial do not differ from risks
associated with non-experimental surgery for this condition. Patients will
receive the standard treatment in addition to the extra care that is provided
to them in the framework of this study. Patients in the experimental arm could
have added value from imaging with use of IMAGE1 S* , since it is expected to
improve the sensitivity of the diagnostic tool for assessing bladder cancer.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled for treatment of a primary or recurrent NMIBC
Patients aged 18 years or older
Has or has had no tumors in the upper urinary tract
Has had no previous irradiation of the pelvis
Exclusion criteria
Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
Has had instillation therapy in the six months prior to the screening visit
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50451.018.14 |