FDA clears NBI for targeting bladder Ca biopsies

December 15, 2014

Olympus has announced the FDA 510(k) clearance of Narrow Band Imaging as enabling effective targeting of biopsies not seen under white light and improved visualization of tumor margins in nonmuscle-invasive bladder cancer.

Olympus has announced the FDA 510(k) clearance of Narrow Band Imaging (NBI) as enabling effective targeting of biopsies not seen under white light and improved visualization of tumor margins in nonmuscle-invasive bladder cancer (NMIBC).

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Experts in urologic cancer say the approval is a significant advance that will ultimately improve the outcomes of patients with NMIBC.

Based on a weighted average, the aggregated FDA-reviewed studies(Int J Urol 2013; 20:602-9) show NBI has visualized NMIBC lesions in:

  • 17% additional patients when compared with white light

  • 24% additional tumors

  • 28% additional carcinoma in situ (CIS).

This finding provides new treatment opportunities for urologists both in the office and in the operating room, according to a statement from Olympus. Additionally, it offers the potential for improved cost reduction and better patient outcomes resulting from earlier detection.

NBI enables effective targeting of biopsies not seen under white light without the use of dyes or drugs. It is not intended to replace histopathologic sampling as a means of diagnosis. NBI enhances visibility of vascular structures on the mucosal surface. Unlike white light, which uses all colors in the spectrum, NBI uses only blue and green, which are strongly absorbed by blood and appear darker than normal tissue.

NBI’s potential visualization of bladder cancer symptoms has been acknowledged by the medical community, but in 2013 a meta-analysis reviewed more than 30 studies on the topic, enough to submit to the FDA, according to Olympus.

“The detection of occult lesions in patients with de novo and recurrent bladder cancer results in markedly improved outcomes,” said Daniel Canter, MD, of the Urologic Institute of Southeastern Pennsylvania and Fox Chase Cancer Center. “An improved view into the underlying vascularity of the lining of the bladder means an improved ability to detect and treat not just the visible, obvious tumors but also the lesions that may have been missed with traditional white light cystoscopy only.

“This is something most urologists have known and would agree with, but it is now backed by the FDA, which should translate into improved patient care.”

 

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J. Brantley Thrasher, MD, of the University of Kansas Medical Center in Kansas City, also said the approval was an important advance for both patients and urologists.

“So often we are left to randomly biopsy bladders based on erythematous areas or positive cytologies. Any technology that allows us to better identify tumors helps us and the patient,” said Dr. Thrasher, a Urology Times editorial consultant. “In the long run, this may very well help us more accurately target tumors and decrease random biopsies.”

White light cystoscopy misses small papillary tumors or CIS at an estimated rate of 10% to 20%. About half of patients who go undiagnosed with CIS will progress to muscle-invasive disease and require cystectomy. Ninety-six percent of patients diagnosed early will survive 5 years later.

NBI can be used for NMIBC as a diagnostic tool in the office/clinic for cystoscopy and as a surgical aide in the O.R. or ambulatory surgical center for transurethral resection.

In the office, NBI allows small tumors to be fulgurated and prevent O.R. visits if visualized early enough, reducing costs associated with a costly-to-treat disease. In addition, NBI does not require the patient to take drugs or experience the discomfort of maintaining a full bladder. NBI is available in both flexible and rigid endoscopes with no contraindications, Olympus said.

In the O.R., NBI can be used prior to resection to enable effective targeting of biopsies not seen under white light. During resection, NBI can be used to enhance visibility of tumor margins. Unlike technologies that strip out colors after taking the image with white light, NBI is filtered at the light source to allow application of only blue and green, providing a deeper enhancement of vasculature.

Olympus has developed an NBI urology app for physicians, available in the App Store with the “Olympus NBI” search terms. The app includes 28 clinical case images, a technology overview, comparison photos of white light and NBI, with an interactive slider and the option to email a case summary to a consulting physician, staff member, or patient.

Dr. Canter is a paid consultant of Olympus.

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