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

No AccessJournal of UrologyAdult urology1 Jul 2007A 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 Studyis accompanied byIncreased SKP2 and CKS1 Gene Expression Contributes to the Progression of Human Urothelial Carcinoma Yves Fradet, H. Barton Grossman, Leonard Gomella, Seth Lerner, Michael Cookson, David Albala, Michael J. Droller, and PC B302/01 Study Group Yves FradetYves Fradet L’Hotel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Québec, Province de Québec, Canada More articles by this author , H. Barton GrossmanH. Barton Grossman University of Texas M. D. Anderson Cancer Center, Houston, Texas Financial interest and/or other relationship with PhotoCure and GE Healthcare. More articles by this author , Leonard GomellaLeonard Gomella Thomas Jefferson Medical Center, Philadelphia, Pennsylvania Financial interest and/or other relationship with PhotoCure and American Urological Association. More articles by this author , Seth LernerSeth Lerner Baylor College of Medicine, Houston, Texas Financial interest and/or other relationship with PhotoCure. More articles by this author , Michael CooksonMichael Cookson Vanderbilt University Medical Center, Nashville, Tennessee Financial interest and/or other relationship with GlaxoSmithKline, Ethicon, Sanofi-Aventis, PhotoCure, National Institutes of Health and GTX. More articles by this author , David AlbalaDavid Albala Duke University Medical Center, North Carolina Financial interest and/or other relationship with Sanofi-Aventis, GlaxoSmithKline, PhotoCure, Lilly-ICOS and Applied Medical. More articles by this author , Michael J. DrollerMichael J. Droller Mount Sinai Medical Center, New York, New York on behalf of the PC B302/01 Study Group More articles by this author , and PC B302/01 Study Group More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2007.03.028AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We compared hexaminolevulinate (Hexvix®) fluorescence cystoscopy with white light cystoscopy for detecting carcinoma in situ. Materials and Methods: In this multicenter study 298 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM hexaminolevulinate for 1 hour. Cystoscopy was then performed, first using standard white light and then hexaminolevulinate fluorescence cystoscopy. Lesions or suspicious areas identified under the 2 illumination conditions were mapped and biopsied for histological examination. In addition, 1 directed biopsy was obtained from an area appearing to be normal. Results: Of 196 evaluable patients 29.6% (58 of 196) had carcinoma in situ, including 18 with carcinoma in situ alone, and 35 with carcinoma in situ and concomitant papillary disease, which was only detected on random biopsy in 5. Of the 18 patients with no concomitant papillary disease carcinoma in situ was detected only by hexaminolevulinate fluorescence in 4 and only by white light in 4. In the group with concomitant papillary disease carcinoma in situ was found only by hexaminolevulinate fluorescence in 5 patients and only by white light in 3. The proportion of patients in whom 1 or more carcinoma in situ lesions were found only by hexaminolevulinate cystoscopy was greater than the hypothesized 5% (p = 0.0022). Overall more carcinoma in situ lesions were found by hexaminolevulinate than by white light cystoscopy in 22 of 58 patients (41.5%), while the converse occurred in 8 of 58 (15.1%). Biopsy results confirmed cystoscopy findings. Of a total of 113 carcinoma in situ lesions in 58 patients 104 (92%) were detected by hexaminolevulinate cystoscopy and 77 (68%) were detected by white light cystoscopy, while 5 were detected only on directed visually normal mucosal biopsy. Hexaminolevulinate instillation was well tolerated with no local or systemic side effects. Conclusions: In patients with bladder cancer hexaminolevulinate fluorescence cystoscopy with blue light can diagnose carcinoma in situ that may be missed with white light cystoscopy. Hexaminolevulinate fluorescence cystoscopy can be used in conjunction with white light cystoscopy to aid in the diagnosis of this form of bladder cancer. References 1 : Serial multiple-site biopsies in patients with bladder cancer. J Urol1978; 120: 57. Link, Google Scholar 2 : Accuracy of urinary cytology in the diagnosis of primary and recurrent bladder cancer. Acta Cytol1993; 37: 163. 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Google Scholar © 2007 by American Urological AssociationFiguresReferencesRelatedDetailsCited byChappidi M, Yang H, Meng M, Bivalacqua T, Daneshmand S, Holzbeierlein J, Kaimakliotis H, Konety B, Liao J, Pohar K, Steinberg G, Taylor J, Tyson M, Willard B, Lotan Y, Porten S and Kates M (2021) Utility of Blue Light Cystoscopy for Post-bacillus Calmette-Guérin Bladder Cancer Recurrence Detection: Implications for Clinical Trial Recruitment and Study ComparisonsJournal of Urology, VOL. 207, NO. 3, (534-540), Online publication date: 1-Mar-2022.Daneshmand S, Patel S, Lotan Y, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Jones J, O’Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M and Jones J (2017) Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter StudyJournal of Urology, VOL. 199, NO. 5, (1158-1165), Online publication date: 1-May-2018.Black P (2014) Bladder Tumor Resection: Doing it RightJournal of Urology, VOL. 191, NO. 6, (1646-1647), Online publication date: 1-Jun-2014.Richards K, Smith N and Steinberg G (2014) The Importance of Transurethral Resection of Bladder Tumor in the Management of Nonmuscle Invasive Bladder Cancer: A Systematic Review of Novel TechnologiesJournal of Urology, VOL. 191, NO. 6, (1655-1664), Online publication date: 1-Jun-2014.Grossman H, Stenzl A, Fradet Y, Mynderse L, Kriegmair M, Witjes J, Soloway M, Karl A and Burger M (2012) Long-Term Decrease in Bladder Cancer Recurrence with Hexaminolevulinate Enabled Fluorescence CystoscopyJournal of Urology, VOL. 188, NO. 1, (58-62), Online publication date: 1-Jul-2012.Ren H, Park K, Pan R, Waltzer W, Shroyer K and Pan Y (2012) Early Detection of Carcinoma In Situ of the Bladder: A Comparative Study of White Light Cystoscopy, Narrow Band Imaging, 5-ALA Fluorescence Cystoscopy and 3-Dimensional Optical Coherence TomographyJournal of Urology, VOL. 187, NO. 3, (1063-1070), Online publication date: 1-Mar-2012.Stenzl A, Burger M, Fradet Y, Mynderse L, Soloway M, Witjes J, Kriegmair M, Karl A, Shen Y and Grossman H (2010) Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients With Nonmuscle Invasive Bladder CancerJournal of Urology, VOL. 184, NO. 5, (1907-1914), Online publication date: 1-Nov-2010.Ren H, Yuan Z, Waltzer W, Shroyer K and Pan Y (2010) Enhancing Detection of Bladder Carcinoma In Situ by 3-Dimensional Optical Coherence TomographyJournal of Urology, VOL. 184, NO. 4, (1499-1506), Online publication date: 1-Oct-2010.Related articlesJournal of Urology14 May 2007Increased SKP2 and CKS1 Gene Expression Contributes to the Progression of Human Urothelial Carcinoma Volume 178Issue 1July 2007Page: 68-73 Advertisement Copyright & Permissions© 2007 by American Urological AssociationKeywordscarcinoma in situcystoscopybladderfluorescence5-aminolevulinic acid hexyl esterAcknowledgmentsStatistical analysis was done at Clinical Datacare, Sweden.MetricsAuthor Information Yves Fradet L’Hotel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Québec, Province de Québec, Canada More articles by this author H. Barton Grossman University of Texas M. D. Anderson Cancer Center, Houston, Texas Financial interest and/or other relationship with PhotoCure and GE Healthcare. More articles by this author Leonard Gomella Thomas Jefferson Medical Center, Philadelphia, Pennsylvania Financial interest and/or other relationship with PhotoCure and American Urological Association. More articles by this author Seth Lerner Baylor College of Medicine, Houston, Texas Financial interest and/or other relationship with PhotoCure. More articles by this author Michael Cookson Vanderbilt University Medical Center, Nashville, Tennessee Financial interest and/or other relationship with GlaxoSmithKline, Ethicon, Sanofi-Aventis, PhotoCure, National Institutes of Health and GTX. More articles by this author David Albala Duke University Medical Center, North Carolina Financial interest and/or other relationship with Sanofi-Aventis, GlaxoSmithKline, PhotoCure, Lilly-ICOS and Applied Medical. More articles by this author Michael J. Droller Mount Sinai Medical Center, New York, New York on behalf of the PC B302/01 Study Group More articles by this author PC B302/01 Study Group More articles by this author Expand All Advertisement PDF downloadLoading ...