Sponsored by Photocure, Inc.

An Interview with Kristen Scarpato, MD, MPH

Kristen Scarpato, M.D., M.P.H., is an Associate Professor of Urology at Vanderbilt University Medical Center, where she completed a fellowship in Urologic Oncology. She is the Program Director for the Urology Residency and the Vice Chair of Education for the Department of Urology. Dr. Scarpato is experienced with Blue Light Cystoscopy (BLC®) and enthusiastic about the practical benefits of the improvements of BLC powered by SAPHIRA.

Blue Light Cystoscopy, which uses fluorescence to color tumors or lesions vivid pink, while healthy tissue remains blue, allows the visualization of bladder cancer that is not readily apparent when using White Light Cystoscopy (WLC) alone. Mild discoloration, flat lesions or papillary lesions that are not particularly raised can be missed when only WLC is used. With BLC, the borders of the harder-to-see areas can be seen more easily because of the fluorescence. Better visibility can mean a more complete resection. BLC has been clinically proven to better detect non-muscle invasive bladder cancer (NMIBC) tumors and can aid in more accurately identifying tumor type, stage and grade when compared to WLC alone. BLC allows for confidence in patient monitoring and aids in determining the appropriate course of action for disease management.

“I feel better about assessing response to therapy when BLC is an option. For patients who are high risk or those I am concerned about after their induction therapy I use BLC and a transurethral resection of bladder tumor (TURBT). If that’s negative, I feel much better than just surveying them with WLC alone. With the high rates of recurrence and regression in bladder cancer, the enhanced detection of the BLC procedure gives both the provider and the patient additional comfort.”

Blue Light Powered by SAPHIRA™

Dr. Scarpato knows how important efficiency in the operating room can be, which is why she is excited about the new Blue Light powered by SAPHIRA™ system. This new system has a simplified set-up process that is much easier to initiate; lighter, more flexible cords; improved toggle location; and remarkably crystal-clear image quality.

“SAPHIRA is an improved blue light system that allows you to perform your cystoscopy and bladder tumor resection or biopsy in a much more efficient and satisfying way. The white light within this system is far superior to any standard white light system I have ever used before. And the CHROMA feature provides high definition and impressive clarity. The blue light setting provides multiple levels of intensity that allow enhanced differentiation between abnormal and normal tissue. SAPHIRA takes the guesswork out of the procedure and makes it really obvious where you should be concerned, and how complete and wide you should go with your resection. There is really no question between normal and abnormal with this new system. It allows for a user-friendly, safe, efficient, and really clear TURBT. If you are doing a better resection more efficiently, everybody wins.”

In Dr. Scarpato’s experience the CHROMA setting allowed her to see the different layers of the bladder, as well as the urothelium moving across the muscularis. This helps ensure that muscle is included in the specimen, which is essential for a high-quality TURBT. Dr. Scarpato also noted that blood vessels were very clearly seen as cancers can be associated with vascularity and an increase in blood vessels,

Images of the same area of interest in a flat, carcinoma in situ bladder lesion: a) White Light Cystoscopy, b) CHROMA, c) Blue Light Cystoscopy.

“This new system is just better across all levels. It’s not just one thing that is different, it’s the whole experience. The whole package has improved, which is noteworthy not just for the surgeon, but for all members of the team. Also, someone who is interested in learning this technology will find it easier to adopt, resulting in a short learning curve. I really do believe that this is so much better for patient care because I think it’s so far superior. In a space where we have not seen a lot of technological or other advancements for quite some time, this system has been an important development that has really changed my practice.”

– Kristen Scarpato, MD, MPH

Dr. Kristen Scarpato is a paid Photocure consultant. 

Indication for Cysview® (hexaminolevulinate HCl)

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder.

Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC^®) as an adjunct to White Light Cystoscopy.

Important Risk & Safety Information for Cysview®

Limitations of Use

Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Warnings and Precautions

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.

Contraindications

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Cysview may fail to detect some malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, and recent BCG therapy or intravesical chemotherapy. No specific drug interaction studies have been performed.

Use in Specific Populations

Safety and effectiveness have not been established in pediatric patients. There are no available data on Cysview use in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal. There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cysview and any potential adverse effects on the breastfed infant from Cysview or from the underlying maternal condition.

Use of the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System

Cysview is approved for use with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the KARL STORZ instruction manuals for each of the components.

Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and reconstitution instructions.