Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy - Full Text View

Sponsor:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00233402

Purpose

The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

Condition	Intervention	Phase
Bladder Cancer	Drug: Hexvix	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Hexyl 5-aminolevulinate

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

To compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
To compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of detection rate of histologically confirmed bladder lesions of Hexvix cystoscopy and white light cystoscopy. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Comparison of the proportion of false positive lesions of Hexvix cystoscopy and white light cystoscopy. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Evaluation of the clinical usefulness of Hexvix cystoscopy compared to standard cystoscopy. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Evaluation of the safety of Hexvix in patients with bladder cancer. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	789
Study Start Date:	January 2005
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Standard White Light Cystoscopy	Drug: Hexvix Single Instillation, Transurethral Resection of the Bladder
Experimental: 2 Standard White Light and Hexvix Fluorescence Cystoscopy	Drug: Hexvix Single Instillation, Transurethral Resection of the Bladder

Detailed Description:

In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patients should be indicated for a cystoscopic examination for suspected or verified papillary bladder cancer and fulfill one or more of the following criteria:

Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.
Patients having recurrence within 12 months confirmed on an outpatient cystoscopy
Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy

Exclusion Criteria:

Patients with known tumors in the prostatic urethra or distal urethra
Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
Patient with porphyria.
Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.
Conditions associated with a risk of poor protocol compliance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233402

Show 25 Study Locations

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

H Barton Grossman

The University of Texas, MD Anderson Cancer Center, Department of Urology

More Information

Publications:

Schmidbauer J, Witjes F, Schmeller N, Donat R, Susani M, Marberger M; Hexvix PCB301/01 Study Group. Improved detection of urothelial carcinoma in situ with hexaminolevulinate fluorescence cystoscopy. J Urol. 2004 Jan;171(1):135-8.

Witjes JA, Moonen PM, van der Heijden AG. Comparison of hexaminolevulinate based flexible and rigid fluorescence cystoscopy with rigid white light cystoscopy in bladder cancer: results of a prospective Phase II study. Eur Urol. 2005 Mar;47(3):319-22. Epub 2005 Jan 1.

Jichlinski P, Guillou L, Karlsen SJ, Malmstrom PU, Jocham D, Brennhovd B, Johansson E, Gartner T, Lange N, van den Bergh H, Leisinger HJ. Hexyl aminolevulinate fluorescence cystoscopy: new diagnostic tool for photodiagnosis of superficial bladder cancer--a multicenter study. J Urol. 2003 Jul;170(1):226-9.

van der Meijden AP, Sylvester R, Oosterlinck W, Solsona E, Boehle A, Lobel B, Rintala E; for the EAU Working Party on Non Muscle Invasive Bladder Cancer. EAU guidelines on the diagnosis and treatment of urothelial carcinoma in situ. Eur Urol. 2005 Sep;48(3):363-71.

Loidl W, Schmidbauer J, Susani M, Marberger M. Flexible cystoscopy assisted by hexaminolevulinate induced fluorescence: a new approach for bladder cancer detection and surveillance? Eur Urol. 2005 Mar;47(3):323-6. Epub 2004 Dec 30.

Jocham D, Witjes F, Wagner S, Zeylemaker B, van Moorselaar J, Grimm MO, Muschter R, Popken G, Konig F, Knuchel R, Kurth KH. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study. J Urol. 2005 Sep;174(3):862-6; discussion 866.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stenzl A, Burger M, Fradet Y, Mynderse LA, Soloway MS, Witjes JA, Kriegmair M, Karl A, Shen Y, Grossman HB. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010 Nov;184(5):1907-13. Epub 2010 Sep 17.

Responsible Party:	Mona Welschof, Photocure ASA
ClinicalTrials.gov Identifier:	NCT00233402 History of Changes
Other Study ID Numbers:	PC B305/02
Study First Received:	October 4, 2005
Last Updated:	September 11, 2009
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by PhotoCure:

Bladder Cancer
Hexvix
Fluorescence
Cystoscopy

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012