Bladder Cancer Clinical Trial
Official title:
A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer
Verified date | May 2018 |
Source | Photocure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
Status | Completed |
Enrollment | 304 |
Est. completion date | April 5, 2017 |
Est. primary completion date | April 5, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be
included only at the first surveillance cystoscopy after a histologically confirmed
tumor. The histologically confirmed tumor could either be from a TURB or from a
surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by
histology) 2. History of one or more of the following: - Multiple tumors - Recurrent tumors - High grade tumor(s) Exclusion Criteria: 1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy) 2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy) 3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure 4. Porphyria 5. Known allergy to hexaminolevulinate hydrochloride or a similar compound 6. Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study 7. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days 8. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 9. Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of North Carolina, Department of Urology | Chapel Hill | North Carolina |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | Ohio State University The James Cancer Hospital | Columbus | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | USC Norris Comprehensive Cancer Center | Los Angeles | California |
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Columbia University Medical Center | New York | New York |
United States | NYU Langone Urology Associates | New York | New York |
United States | University of Oklahoma-Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Photocure | KARL STORZ Endoscopy-America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy | In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured. | At time of cystoscopy procedure | |
Secondary | Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination | At time of cystoscopy procedure | ||
Secondary | Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy | In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured. | At time of cystoscopy procedure |
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