Bladder Cancer Imaging Study-OCT Imaging to Stage Bladder Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seth Lerner, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00831558
First received: January 27, 2009
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

The Niris™ OCT Imaging System is a device used in the operating room together with cystoscopy in order to be able to see the condition of the bladder wall. The current implementation of the fiber optic based OCT probe has a 2.7mm (OD) which easily integrates with standard cystoscopy equipment. It builds on the basic skills of conventional cystoscopy, making it straight-forward to learn and simple to use. Imaging data are captured quickly with a 1.5 second scan time per image. The data acquisition module is smaller than a desktop computer and permits real-time capture of data in a digital format. OCT offers a rapid, minimally-invasive adjunct to white light cystoscopy that may aid in diagnosis and staging of bladder cancer. The image it produces has been proven to show tumors that go deeper than first thought and to show tumors in the earliest stages. The ability to find bladder tumors at the earliest stage and to remove and treat the bladder to prevent recurrence has been proven to be the key to long-term cancer control.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography as an Adjunct to White Light Cystoscopy for Intravesical Real Time Imaging and Staging of Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Assessment of accuracy and positive predictive value of OCT for determining tumor stage correlated by histopathology [ Time Frame: Upon receipt of data ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate cystoscopic stage and grade,surgeon's interpretation of OCT images with histopathologic stage and grade [ Time Frame: Upon receipt of data ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: March 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
  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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with a bladder tumor to be rescted in the operating room

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831558

Locations
United States, Texas
Baylor College of Medicne
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Seth P. Lerner, M.D. BCM
  More Information

No publications provided

Responsible Party: Seth Lerner, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00831558     History of Changes
Other Study ID Numbers: H#21830 Imalux, Imalux Corp. v.12-31-07
Study First Received: January 27, 2009
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
bladder tumor
imaging studies

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014