Phase III Clinical trials using Hexvix:
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Hexvix Cystoscopy for Detection of Bladder Cancer
Current Opinion in Urology September 2007:
Fluorescence cystoscopy shows significant improvement in the detection of flat bladder cancer, CIS/carcinoma in situ, and neoplastic lesions with multifocal tumors, which translates to better resection and lower recurrence rates.
New agents bring a significant benefit. Hexvix is simple to use in everyday practice and has a favorable toxicity profile.
Recent developments in fluorescence cystoscopy: do novel agents bring a benefit?.
Current Opinion in Urology. 17(5):347-351, September 2007.
Schmidbauer, Jorg; Marberger, Michael
For a list of European hospitals using Hexvix see below.
Update July ’07 Hexvix Cystoscopy Detects At Least One More Papillary Tumour Than White Light Cystoscopy Alone In 29% Of Patients
Gold Standard Becomes Platinum:
Cystoscopy is still the gold standard for detecting bladder tumors. Unfortunately, [white light] cystoscopes, either flexible or rigid, miss up to 45% of multiple tumors, 20% of single tumors and around 30% of CIS disease.
Photodynamic Diagnosis (PDD), fluorescent, blue light cystoscopy –
Approved in Europe, still in trials in the US, this diagnostic tool has been shown to be a significant improvement over white light cystoscopy with NO side effects beyond those normally occurring during routine cystoscopy. The addition of Hexvix improves the detection of the number of CIS lesions per patient and also the number of patients with CIS.1 Carcinoma in situ is one of the most dangerous forms of bladder cancer because it is difficult to see.
Hexvix identifies approximately 30% more patients with CIS (carcinoma in situ) compared to standard cystoscopy.
Although the use of fluorescence cystoscopy/PDD improves the detection rate of CIS to more than 95 % it has not yet been implemented on a regular basis in daily practice. The European Association of Urology’s latest guidelines represent state-of-the-art recommendations, and use of fluorescent cystoscopy is now included in their guidelines for non-invasive bladder cancer.
A solution is instilled into the bladder and held for one hour before the florescent light cystoscopy is performed. There are no side effects apart from those expected after a regular white light cystoscopy is performed. 2.4% of adverse side effects were thought to be product related in the largest clinical trial to date. 3
Phase III clinical trials are ongoing in the US, and Hexvix now has investigational new drug status from the FDA, with approval hoped for shortly. A New Drug Application (NDA) was submitted in June 2005 in the United States and if approved by the FDA it would be the first optical molecular imaging agent of its kind available to the US market.
Jan. ’05:GE Healthcare, a unit of General Electric Company (NYSE:GE), and PhotoCure ASA (OSE:PHO) announced a licensing agreement that grants GE Healthcare an exclusive option for GE Healthcare to market and distribute the product in the US.
Update, Journal of Urology, 7-’07:
The authors reporting the results of a phase III clinical trial showed that improvement in detection rate for pTa tumours was statistically significant, with rates of 95% for Hexvix cystoscopy compared to 83% for white light cystoscopy. The early detection and excision of such papillary tumours could lead to improved patient outcomes by prolonging the time when they are free of the disease, although this has yet to be shown in a clinical trial. 3
UK Hospitals Using Hexvix
Barnet and Chase Farm
Guys and St Thomas
UCLH (University College London Hospital)
Castle Hill (Hull)
BMI Hampshire Clinic
Chelsea and Westminster
Leicester Royal Infirmary
Adelaide and Meath (Dublin)
NL Hospitals Using Hexvix
This is not yet a complete list.
1. Pub Med Abstract: Bladder carcinoma in situ in 2003: state of the art. Witjes JA. Department of Urology, University Medical Center St Radboud, Nijmegen, The Netherlands. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study. Jocham D, Witjes F, Wagner S, Zeylemaker B, van Moorselaar J, Grimm MO, Muschter R, Popken G, Konig F, Knuchel R, Kurth KH. Department of Urology, University of Schleswig-Holstein, Lubeck, Germany. J Urol. 2005 Sep;174(3):862-6; discussion 866.
2. 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. Fradet Y, Grossman HB, Gomella L, Lerner S, Cookson M, Albala D, Droller MJ; PC B302/01 Study Group. L’Hotel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Québec, Province de Québec, Canada. bJ Urol. 2007 Jul;178(1):68-73; discussion 73. Epub 2007 May 1 PMID: 17499291 [PubMed – indexed for MEDLINE]
3. 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. H. Barton Grossman, Michael J. Droller et al. J Urol. Vol. 178, 62-67, July 2007.