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Optical Coherence Tomography as an Adjunct to White Light Cystoscopy for Intravesical Real Time Imaging and Staging of Bladder Cancer

18 Years
65 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

Optical Coherence Tomography as an Adjunct to White Light Cystoscopy for Intravesical Real Time Imaging and Staging of Bladder Cancer

Bladder cancer is the fourth most common cancer in men and the eighth most common in women
with approximately 60,000 new cases diagnosed every year. The highest occurrence of bladder
cancer is found in industrialized countries such as the United States, Canada, Denmark,
Italy and Spain. The incidence is three to four times higher in men compared with women, and
the incidence rises with age. Among white men, the annual incidence after the age of 65 is
approximately two per 1000 people and the lifetime chance of developing bladder cancer is
over 3%.

The majority of patients have non-muscle invasive bladder cancer (cancer that has not spread
into the bladder muscle) which can be controlled, but survival depends upon early detection
of the cancer. In the 20 years following diagnosis, there is a recurrence rate (the cancer
returns after treatment) of 50 to 75%, a progression rate (cancer recurs and is now
invasive) of 10 to 40% and a death rate of 10 to 30%.

Optical coherence tomography (OCT) was first used to image human tissue in 1991 and has been
developed for clinical applications since that time. OCT employs light (instead of sound
waves) to obtain images in a manner analogous to B-mode ultrasonography performing
real-time, 10-20 micron scale imaging, nearing the resolution of histopathology. OCT
performs two- and three-dimensional imaging in biological tissues by directing harmless near
infrared light onto the tissue and measuring the reflected or backscattered intensity of
light as a function of depth[1]. Direct comparisons have been performed between OCT and the
current clinical technology with the highest resolution, high frequency ultrasound. OCT
demonstrated superior performance both quantitatively and qualitatively. The potential
clinical use of OCT in the bladder is closely related to cystoscopic imaging with white
light. The complementary use of OCT with standard cystoscopy allows acquisition of real-time
images of regions of interest at a depth of up to 2mm and a spatial resolution of ~10-20 um.
Furthermore, OCT technology is fiber-optic based, which allows its relatively
straightforward integration with small catheters and cystoscopes. OCT imaging is performed
in real-time making it an attractive technology for implementation as a single episode
point-of-care diagnostic, monitoring and surgical-guiding tool. Finally, as an optical
imaging technology, OCT can be combined with other optical modalities such as absorption and
polarization spectroscopy.

Inclusion Criteria:

1. Patients demonstrating one or more papillary tumors of the urinary bladder amenable
to complete resection (Clinical stage Ta or T1) and not requiring a cystectomy, as
identified by outpatient cystoscopy

2. Patients with a positive cytology or FISH with or without visible tumor

Exclusion Criteria:

1. Tumor at Bladder neck

2. Under 21 years of age

3. Pregnancy or breast feeding

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Assessment of accuracy and positive predictive value of OCT for determining tumor stage correlated by histopathology

Outcome Time Frame:

Upon receipt of data

Safety Issue:


Principal Investigator

Seth P. Lerner, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:

H#21830 Imalux



Start Date:

March 2008

Completion Date:

March 2014

Related Keywords:

  • Bladder Cancer
  • bladder tumor
  • imaging studies
  • Urinary Bladder Neoplasms



Baylor College of Medicne Houston, Texas  77030