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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
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Nadeem N Dhanani, The University of Texas Health Science Center, Houston

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Bladder Cancer Detection Imaging [ Time Frame: 10 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 protocol procedures.
  2. Women with the possibility of having the pregnancy.
  3. Patients having acute infection.
  4. Person with Lidocaine sensitivity.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
William Marsh Rice University
Investigators
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Principal Investigator: Nadeem N Dhanani, MD MPH The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Nadeem N Dhanani, The University of Texas Health Science Center, Houston:

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Responsible Party: Nadeem N Dhanani, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02340650     History of Changes
Other Study ID Numbers: HSC_MS_14_0144
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nadeem N Dhanani, The University of Texas Health Science Center, Houston:
suspicious bladder lesion, normal bladder tissue

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases