High Resolution Imaging for Early and Better Detection of Bladder Cancer (HRME_Bladder)

June 22, 2021 updated by: Nadeem N Dhanani, The University of Texas Health Science Center, Houston
The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77026
        • Lyndon B. Johnson General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential subjects will be identified from patients who are visiting Lyndon B. Johnson Hospital (LBJ) Houston for evaluation of bladder cancer or a suspicious bladder lesion/clinical symptomatology by cystoscopy and bladder biopsy or from LBJ patients who are undergoing cystoscopy as part of their routine clinical care.

Description

Inclusion Criteria:

  • Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care.
  • Must be willing and able to participate and provide written informed consent
  • Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation

Exclusion Criteria:

  • 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.
  • Women with the possibility of having the pregnancy.
  • Patients having acute infection.
  • Person with Lidocaine sensitivity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bladder Cancer Patients
High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.
Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
Other Names:
  • HRME and/or LSC-HRME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specificity of Bladder Cancer Detection Imaging
Time Frame: baseline (at the time of imaging)
baseline (at the time of imaging)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

William Marsh Rice University

Investigators

  • Principal Investigator: Nadeem N Dhanani, MD MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-14-0144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope

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