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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

To compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer.

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

H Barton Grossman

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

PC B305/02

NCT ID:

NCT00233402

Start Date:

January 2005

Completion Date:

August 2008

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Hexvix
  • Fluorescence
  • Cystoscopy
  • Urinary Bladder Neoplasms
  • Recurrence

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601
Boston University School of MedicineBoston, Massachusetts  02118
University of Miami School of MedicineMiami, Florida  33136
Stanford Cancer Center, Department of UrologyStanford, California  94305-5820
V.A. Medical CenterGainesville, Florida  32608
South Florida Clinical Research Center, Inc.Pembroke Pines, Florida  33028
The Emory Clinic, Dept of UrologyAtlanta, Georgia  30322
St. Joseph Mercy Hospital- Ann ArborAnn Arbor, Michigan  48106
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic RochesterRochester, Minnesota  55905
Mount Sinai Medical Center, Department of UrologyNew York, New York  10029-6574
URMCRochester, New York  14642
Urological Institute at Beachwood Cleveland ClinicBeachwood, Ohio  44120
Thomas Jefferson Medical College, Department of NeurologyPhiladelphia, Pennsylvania  19107
Vanderbilt University Medical Center, Department of Urologic SurgeryNashville, Tennessee  37232-2765
Baylor College of Medicine, Scott Department of UrologyHouston, Texas  77030-2726