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Clinical Aspects of Bladder Cancer

Clinical Situation in general

Urinary bladder cancer has a recurrence rate of between 50% and 75% at 20 years1 after treatment.

As a consequence, highly sensitive as well as specific diagnostic techniques capable of comprehensively detecting as many tumors as possible must be employed in order to ensure optimal treatment. 

Diagnosis: Techniques and Tools

Cystoscopy and urinary cytology are both used in the diagnosis and monitoring of bladder cancer.

Standard white light cystoscopy
Cystoscopy allows for direct visual inspection of the urothelium and mucosa. Cystoscopy-guided biopsy, ie, transurethral resection (TUR) of suspicious lesions and areas remains the standard procedure for detection of bladder cancer. 

Urinary cytology
Urinary cytology has both a high specificity and sensitivity towards the detection of high-grade lesions thus constituting the noninvasive tool of choice for bladder cancer diagnosis. Urinary markers, which also may be employed, appear to have better sensitivity especially for low-grade non-muscle invasive tumors, but lack the specificity associated with cytology. The most serious drawbacks of both cytology and urinary markers are that results are not immediately available, are highly dependent on the interpreter, and provide no information on the location and extent of the disease.2 


The Present Diagnosis Situation

Missed diagnosis leading to delayed or incomplete treatment has significant prognostic implications for patients with potentially aggressive tumors, such as CIS. Furthermore, missed diagnosis contributes to the high rate of recurrence of non-muscle-invasive cancers after TUR and it carries considerable economic costs through additional medical interventions necessary after initial treatment.2,3


Two new approaches to improve the diagnostic situation are bladder tumor markers which are currently being studied extensively, including fluorescence cystoscopy with Cysview Blue Light cystoscopy which is now approved in the US. 


References

  1. Grossman H, Gomella L, Fradet Y et al. A phase III, multicenter comparison of hexaminolevulinate (HAL) fluorescence cystoscopy and white light cystoscopy for the detection of superficial papillary lesions in patients with bladder cancer. Abstract presented at the 99th Annual Meeting of the American Urological Society 2004. Unpublished working paper. 
  2. Frampton JE, Plosker GL. Hexyl Aminolevulinate in the Detection of Bladder Cancer.  Drugs 2006;66:571-8
  3. Daniltchenko DI, Riedl CR, Sachs MD et al. Long-Term Benefit of 5-Aminolevulinic Acid in Fluorescence Assisted Transurethral Resection of Superficial Bladder Cancer: 5-Year Results of a Prospective Randomized Study. J Urol 2005;174: 2129-33. 


Licensed from Photocure ASA. 
Cysview is a trademark of Photocure ASA. 

Scan courtesy of Dirk Zaak, Associate Professor, 
Dept. of Urology, University of Munich, Germany.

 
View of bladder with white light cystoscope followed by view of bladder with blue light
cystoscope
Photo credit - Dr. Maximilian Burger, University of
Regensburg
 

Indications and Usage

Cysview is an optical imaging agent 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.


Product Risk Information:

Safety and effectiveness have not been established in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue light cystoscopy, nor in pediatric patients.

The following adverse reactions have been identified during post-approval use of Cysview. Because these reactions are reported voluntarily
from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of anaphylactoid shock, bladder pain, cystitis and abnormal urinalysis have uncommonly been reported.

Cysview should not be used in patients with porphyria or with known hypersensitivity to hexaminolevulinate. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed.
 
Cysview must be used 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.
 

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