High Resolution Imaging for Early and Better Detection of Bladder Cancer (HRME_Bladder)
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|ClinicalTrials.gov Identifier: NCT02340650|
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : April 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Resolution Imaging for Early and Better Detection of Bladder Cancer|
|Actual Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Bladder Cancer Patients
Subjects aged 18 years and older who have a suspicious bladder lesion or clinical presentation identified by a physician who recommends further evaluation with cystoscopy and bladder biopsy or who are undergoing cystoscopy as part of their routine clinical care.
Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
Other Name: HRME and/or LSC-HRME
- Bladder Cancer Detection Imaging [ Time Frame: 10 minutes ]
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 ClinicalTrials.gov identifier (NCT number): NCT02340650
|Contact: Nadeem N Dhanani, MD MPH||(713) 500-7337||Nadeem.N.Dhanani@uth.tmc.edu|
|Contact: Comalita L. Lee, CRC, BAAS||713.500.6086||Comalita.Lee@UTH.TMC.EDU|
|United States, Texas|
|Lyndon B. Johnson General Hospital||Recruiting|
|Houston, Texas, United States, 77026|
|Contact: Nadeem Dhanani, MD, MPH 713-500-7337|
|Contact: Comalita Lee 713-500-6086|
|Principal Investigator: Nadeem Dhanani, MD, MPH|
|Principal Investigator:||Nadeem N Dhanani, MD MPH||The University of Texas Health Science Center, Houston|