Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients With Nonmuscle Invasive Bladder Cancer
Open accessAbstract
PURPOSE: We assessed the impact that improved detection of nonmuscle invasive bladder cancer with hexaminolevulinate fluorescence cystoscopy may have on early recurrence rates. MATERIALS AND METHODS: This prospective, randomized study enrolled 814 patients suspected of having bladder cancer at increased risk for recurrence. All patients underwent white light cystoscopy and mapping of lesions, followed by transurethral resection of the bladder when indicated. Patients in the fluorescence group also received intravesical hexaminolevulinate solution at least 1 hour before cystoscopy to induce fluorescence of cancerous lesions, and underwent additional inspection with blue light before and after transurethral resection of the bladder. Adjuvant intravesical therapy was based on risk. Followup cystoscopy at 3, 6 and 9 months was conducted with white light. RESULTS: Detection was performed as a within patient comparison in the fluorescence group. In this group 286 patients had at least 1 Ta or T1 tumor (intent to treat). In 47 patients (16%) at least 1 of the tumors was seen only with fluorescence (p = 0.001). During the 9-month followup (intent to treat) there was tumor recurrence in 128 of 271 patients (47%) in the fluorescence group and 157 of 280 (56%) in the white light group (p = 0.026). The relative reduction in recurrence rate was 16%. CONCLUSIONS: Hexaminolevulinate fluorescence cystoscopy significantly improves the detection of Ta and T1 lesions and significantly reduces the rate of tumor recurrence at 9 months.
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FDA approved HAL hydrochloride (Cysview) for the diagnosis of non-muscle (superficial) invasive bladder cancer in 2010.
“Significant improvement in surgical outcomes shown in these clinical trials led to the FDA approval of HAL hydrochloride (Cysview) for the diagnosis of non-muscle (superficial) invasive bladder cancer in 2010.”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [62]
The Conclusion (page not provided) reports improved bladder-cancer detection, more complete resection, and better disease-free survival with hexaminolevulinate fluorescence cystoscopy. Our copy does not state that the FDA approved Cysview in 2010 or that these trial outcomes led to approval. (LLM, conf=0.83)
Experimental — accuracy not yet measuredIn a study with 814 patients, transurethral tumor resection following HAL fluorescence cystoscopy significantly reduced tumor recurrence at 9 months post-surgery compared with the same procedure under white light cystoscopy.
“A following study with 814 patients further demonstrated that transurethral tumor resection following HAL fluorescence cystoscopy significantly reduced tumor recurrence at 9 months post-surgery compared with the same procedure under white light cystoscopy [62].”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [62]
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References 32 · Cited by 304
Research works printed but not linked: 22
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- Authors
- Stenzl, A., Burger, M., Fradet, Y., Mynderse, L. A., Soloway, M. S., Witjes, J. A., Kriegmair, M., Karl, A., Shen, Y., & Grossman, H. B.
- Affiliations
- Universitätsklinikum Tübingen (DE)
- Caritas-Krankenhaus St. Josef (DE)
- Hôtel-Dieu de Québec (CA)
- Mayo Clinic (US)
- University of Miami (US)
- Radboud University Medical Center (NL)
- Urologische Klinik München (DE)
- Ludwig-Maximilians-Universität München (DE)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- Journal of Urology
- Published
- 2010-11
- Volume
- 184
- Issue
- 5
- Pages
- 1907-1914
- ISSN
- 0022-5347 (ISSN-L)
- 1527-3792
- PMC
- PMC4327891
- OpenAlex
- W2131338599
- Cited by
- 304
- References
- 32
- Citations by year
- 2026: 14 · 2025: 8 · 2024: 11 · 2023: 16 · 2022: 19 · 2021: 25 · 2020: 12 · 2019: 14 · 2018: 16 · 2017: 26 · 2016: 19 · 2015: 21 · 2014: 30 · 2013: 23 · 2012: 21
- FWCI
- 24.33
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Urology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P50CA091846)
- Topics
- Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
- Health Sciences › Medicine › Surgery › Urinary and Genital Oncology Studies
- Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
- Keywords
- hexaminolevulinate, fluorescence cystoscopy, non-muscle-invasive bladder cancer, tumor recurrence, tumor detection, blue light cystoscopy, white light cystoscopy, intravesical therapy, transurethral resection of bladder
- MeSH terms
- Aged, Aminolevulinic Acid, Urinary Bladder Neoplasms, Carbon Radioisotopes, Cystoscopy, Female, Fluorescence, Humans, Male, Neoplasm Recurrence, Local, Prospective Studies
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