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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233402
Recruitment Status : Completed
First Posted : October 5, 2005
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
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Brief Summary:
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 or disease Intervention/treatment Phase
Bladder Cancer Drug: Hexvix Procedure: Standard white light cystoscopy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard White Light Cystoscopy Procedure: Standard white light cystoscopy
Experimental: Standard White Light and Hexvix Fluorescence Cystoscopy Drug: Hexvix
Single Instillation, Transurethral Resection of the Bladder
Procedure: Standard white light cystoscopy

Primary Outcome Measures :
  1. Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light [ Time Frame: Day 0 ]
  2. Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy. [ Time Frame: Day 0 ]

    The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).

    The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.

  2. Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light. [ Time Frame: Day 0 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233402

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Sponsors and Collaborators
Principal Investigator: H Barton Grossman The University of Texas, MD Anderson Cancer Center, Department of Urology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Photocure Identifier: NCT00233402     History of Changes
Obsolete Identifiers: NCT00209157
Other Study ID Numbers: PC B305/02
First Posted: October 5, 2005    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013
Last Verified: August 2013

Keywords provided by Photocure:
Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes