This is a pilot study involving 100 subjects. The primary aim will be to conduct image analysis with the use of High resolution micro-endoscope(HRME) and Line-Scanning Confocal High Resolution Micro-endoscope (LSC-HRME) on the profile of normal bladder tissue, inflamed bladder tissue, suspicious bladder tissue and bladder cancer tissues . The secondary aim will be to examine the effectiveness of the new HRME and LSC-HRME device for early diagnosis of bladder cancer with less invasive procedure. This is a pilot study examining imaging analysis in patients with normal bladder tissue, inflamed bladder tissue, suspicious bladder tissue, and bladder cancer who are scheduled to have cystoscopy. This is a cross sectional study therefore, each patient will participate only once in this study. The study involves only 1 visit: Visit #1: schedules cystoscopy and biopsy procedure that are part of standard care and then capturing image with the use of HRME/LSC-HRME device as a part of research procedure. All the procedures performed in this study are normally done in the work-up of patients scheduled to have cystoscopy procedure and is considered a routine procedure for bladder cancer screening. The only procedure/treatment which is not routine is the use of HRME and LSC-HRME. Biopsy will be taken at the time of cystoscopy that involves standard of care. Images taken by HRME/LSC-HRME device will then be correlated with pathology results of the biopsied tissue. The samples will be coded and de-identified data will be sent to Dr. Rebecca Richards-Kortum laboratory for correlation. The blood and urine samples collected during the screening visit are routine tests for patients with bladder cancer and will be handled according to standard of practice. The test results will be included in the subject's research and medical charts. Additional research related information will be provided at the end of the study. Risks include those related to cystoscopy and HRME/LSC-HRME device may include infection, pain, difficulty with urination and blood in urine, perforation. Potential benefits may include to this subject class for early detection of bladder cancer with minimal invasive technique. Understanding the effects of HRME and LSC-HRME device on the bladder screening may improve screening and detection methodologies for future patients with bladder cancer.
|Overal Status||Start Date||Phase||Study Type|
Primary Outcome 1 - Measure: Bladder Cancer Detection Imaging
Primary Outcome 1 - Time Frame: 10 minutes
A. Inclusion Criteria
All participants in this study will be chosen independent of age, sex, and ethnic
background meeting following criteria:
1. Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are
undergoing cystoscopy as part of their routine clinical care.
2. Age 18 years and older
3. Must be willing and able to participate and provide written informed consent
4. Women of childbearing age who have the possibility of being pregnant must have a
negative pregnancy test prior to participation
B. Exclusion Criteria A patient will be excluded if:
1. Patient with sufficient evidence of cognitive impairment that limits the subject's
ability to understand the protocol, provide informed consent, or to comply with the
2. Women with the possibility of having the pregnancy.
3. Patients having acute infection.
4. Person with Lidocaine sensitivity.
Minimum Age: 18 Years
Maximum Age: 100 Years
Healthy Volunteers: No
Name: Nadeem N Dhanani, MD MPH
Role: Principal Investigator
Affiliation: The University of Texas Health Science Center, Houston
Name: Nadeem N Dhanani, MD MPH
Phone: (713) 500-7337
|Lyndon B. Johnson General Hospital
Houston, Texas 77026
Nadeem Dhanani, MD, MPH