High Resolution Imaging for Early and Better Detection of Bladder Cancer
HRME_Bladder
1 other identifier
observational
37
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJune 25, 2021
June 1, 2021
5.5 years
January 13, 2015
June 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Specificity of Bladder Cancer Detection Imaging
baseline (at the time of imaging)
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lyndon B. Johnson General Hospital
Houston, Texas, 77026, United States
Related Publications (1)
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.
PMID: 33307957DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadeem N Dhanani, MD MPH
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 16, 2015
Study Start
April 1, 2015
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
June 25, 2021
Record last verified: 2021-06