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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00233402
First received: October 4, 2005
Last updated: August 5, 2013
Last verified: August 2013
  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
Procedure: Standard white light cystoscopy
Phase 3

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:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

    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.


  • Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by PhotoCure

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00233402     History of Changes
Obsolete Identifiers: NCT00209157
Other Study ID Numbers: PC B305/02
Study First Received: October 4, 2005
Results First Received: August 5, 2013
Last Updated: August 5, 2013
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:
Recurrence
Urinary Bladder Neoplasms
Disease Attributes
Neoplasms
Neoplasms by Site
Pathologic Processes
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014