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CompletedNCT02340650HRME_BladderUpdated Jun 25, 2021

High Resolution Imaging for Early and Better Detection of Bladder Cancer

An observational study in Bladder Cancer, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
37
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Bladder Cancer

Keywords

  • suspicious bladder lesion, normal bladder tissue
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 37 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceStandard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope

    Also known as: HRME and/or LSC-HRME

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What researchers measure

Primary outcomes

  1. Specificity of Bladder Cancer Detection Imaging

    Time frame: baseline (at the time of imaging)

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Study locations

1 site
  • Lyndon B. Johnson General Hospital
    Houston, Texas 77026, United States
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References and documents

Publications

  • Tang Y, Kortum A, Vohra I, Schwarz RA, Carns J, Kannady CR, Clavell-Hernandez J, Hu Z, Dhanani N, Richards-Kortum R. Initial Results of First In Vivo Imaging of Bladder Lesions Using a High-Resolution Confocal Microendoscope. J Endourol. 2021 Aug;35(8):1190-1197. doi: 10.1089/end.2020.0757. Epub 2021 Jan 21. PubMed 33307957 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02340650
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
William Marsh Rice University
Responsible party
Nadeem N Dhanani (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 16, 2015
Start date
Apr 2015
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020
Last update
Jun 25, 2021

Study contacts

Nadeem N Dhanani, MD MPH
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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