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CarolinaEast Medical Center Adopts Innovative Imaging Agent to Improve Detection of Certain Bladder Cancers

Hospital news | Saturday, March 3, 2018

Contact: Megan McGarvey

Blue Light Cystoscopy with Cysview® May Detect Certain Bladder Cancer Tumors More than Use of Standard Diagnostic Technology

(NEW BERN, NC March 3, 2018) –CarolinaEast Medical Center is one of a select number of medical centers nationwide and one of only three in North Carolina offering Blue Light Cystoscopy with Cysview® (hexaminolevulinate hydrochloride), an optical imaging agent for the detection of papillary cancer of the bladder in patients with known or suspected bladder cancer. Cysview is the only FDA-approved imaging agent for use with blue-light cystoscopy.

"Bladder cancer is difficult to detect and has a high rate of recurrence. An inaccurate diagnosis can result in incomplete treatment, which may lead to serious complications and a lower chance of survival for patients with potentially aggressive tumors," noted Patrick Walsh, MD, CarolinaEast Urology. "Blue Light Cystoscopy with Cysview represents an important advance in diagnostic technology, enabling more accurate diagnosis of bladder tumors compared to the standard technique."

Bladder cancer is the sixth most commonly diagnosed cancer in North Carolina and the 11th leading cause of cancer death. The American Cancer Society (ACS) estimates that 72,570 new cases of bladder cancer are diagnosed in the U.S. each year. Between 50 to 80 percent of patients will have their bladder cancer recur making it the highest recurrence rate of any form of cancer according to the ACS.

Additionally, bladder cancer carries the highest lifetime treatment costs per patient of all cancers, with 40 percent of the costs coming from surgical interventions to treat cancer recurrence. Based on a combination of clinical data and economic analyses, a study showed that the five year cost for patients who initially receive blue light cystoscopy as part of their initial bladder cancer surgery were lower than those whose surgery did not include Blue Light.

In the past and presently, white light cystoscopy had been the gold standard for visualizing suspicious lesions during the standard bladder tumor surgery. However, when used on its own, harder-to-see tumors can often be missed. Cysview, which is manufactured by Photocure Inc., is approved by the FDA for photodynamic blue light cystoscopy performed with the KARL STORZ Photodynamic Diagnostic (PDD) system. Cysview works by exploiting fluorescent properties of naturally occurring molecules in malignant tissues.

In Blue-Light Cystoscopy with Cysview,® the imaging solution (Cysview) is delivered into the bladder about an hour prior to the cystoscopy and is absorbed by cancerous tissue. Using the special PDD system, the doctor inserts a long thin tube into the bladder. After first using white light, the doctor will switch to blue light mode. Because of the preferential uptake of Cysview by malignant cells, other hard-to-see tumors that may be present become more visible, standing out against normal bladder tissue and making it easier for the doctor to identify and remove them.

"The availability of Blue Light Cystoscopy with Cysview is in keeping with our commitment to advancing patient care," said Megan McGarvey, CarolinaEast spokesperson. "At CarolinaEast Medical Center eligible patients with known or suspected bladder cancer can now undergo diagnostic procedures administered by physicians who have been specially trained in the use of this innovative technology," she added.

CarolinaEast is one of three medical centers in the state to offer this leading edge technology. The other two are Duke University Medical Center and UNC Health Care.

About Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution

Cysview is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1). Cysview is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

About CarolinaEast Medical Center

CarolinaEast Medical Center has been serving the growing needs of the coastal North Carolina community since 1963. In addition to the system's flagship, 350 bed CarolinaEast Medical Center, CarolinaEast Health System includes a rehabilitation hospital, free standing diagnostic and surgery center and several CarolinaEast Physician practices providing primary and specialty care for all phases of life from offices located in four counties.

Important Risk and Safety Information about Cysview®

Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer and is not for repetitive use. Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed. Using Cysview, fluorescence of non-malignant areas may occur, and Cysview may fail to detect some malignant lesions.

Safety and effectiveness have not been established in pediatric patients. Cysview should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when Cysview is administered to nursing mothers. No clinically important differences in safety or efficacy have been observed between older and younger patients.