Blue Light Cystoscopy With Cysview® Recommended To Enhance Treatment of NMIBC

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Bladder tumor viewed under white-light      Bladder tumor viewed under blue-light

 

“In a patient with Non-Muscle Invasive Bladder Cancer, a clinician should offer blue light cystoscopy at the time of TURBT, if available, to increase detection and decrease recurrence.”
– 2016 Guidelines for diagnosis & treatment of NMIBC 
American Urological Association/ Society for Urologic Oncology 

 

Used as an adjunct to white-light cystoscopy, Blue Light Cystoscopy with Cysview® (hexaminolevulinate HCl) is the only FDA-approved technology that:

  • Has been studied extensively versus use of white-light cystoscopy alone to determine improved detection of bladder cancer tumors3-8
  • Is clinically proven to detect more Ta/T1 bladder cancer lesions vs. white-light cystoscopy alone3-8
  • Leads to improved and more comprehensive tumor resection3-8

 

“For a long time, there has been an unmet medical need for improving the detection of NMIBC tumors and the innovative technology of Blue Light Cystoscopy with Cysview® (BLCC) helps to fill that void! This unique technology allows better detection and resection of both low and high grade tumors enabling better management, continued surveillance and follow up of the patients. With the addition of BLCC to the AUA guidelines as a recommendation with the highest grade of clinical support, this may become a new standard for detection and treatment of NMIBC tumors. At VA Houston, we routinely use BLCC for most patients undergoing TURBT.” 
– Jeffrey Jones, MD
Chief of Urology
Michael E DeBakey VA Houston, TX 

 

Consider Blue Light Cystoscopy with Cysview® to Improve Detection of Bladder Cancer Tumors

Important safety information

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, exercise caution when Cysview is administered to nursing mothers. No clinically important differences in safety or efficacy have been observed between older and younger patients.

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.

For more information on Blue Light Cystoscopy with Cysview®, or other KARL STORZ products, please contact your local KARL STORZ representative at (800) 421-0837. 

 logo_karlstorz_de  photocure

References:

  1. Cysview [prescribing information]. Princeton, NJ: Photocure ASA; 2011.
  2. Frampton JE, Plosker GL. Hexyl aminolevulinate: in the detection of bladder cancer. Drugs. 2006;66(4):571-578.
  3. Schmidbauer J, Witjes F, Schmeller N, et al. Improved detection of urothelial carcinoma in situ with hexaminolevulinate fluorescence cystoscopy. J Urol. 2004;171(1):135-138.
  4. Grossman HB, Gomella L, Fradet Y, et al. A phase III, multicenter comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of superficial papillary lesions in patients with bladder cancer. J Urol. 2007;178(1):62-67.
  5. Fradet Y, Grossman HB, Gomella L, et al. A comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of carcinoma in situ in patients with bladder cancer: a phase III, multicenter study. J Urol. 2007;178(1):68-73.
  6. Jocham D, Witjes F, Wagner S, et al. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study. J Urol. 2005;174(3):862-866.
  7. Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010;184(5):1907-1913.
  8. Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized twocentre study. BJU Int. 2011;108(8 pt 2):E297-303.