Bladder CancerHRME_BladderNCT02340650
High Resolution Imaging for Early and Better Detection of Bladder Cancer
An observational study of Bladder Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
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.
- Conditions
- Bladder Cancer
- Being tested
- Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope
- Keywords
- suspicious bladder lesion, normal bladder tissue
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution MicroendoscopeDevice
Also called HRME and/or LSC-HRME
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of Bladder Cancer Detection Imaging
Measured: baseline (at the time of imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startApr 2015
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University
- Responsible party
- Principal investigator, Nadeem N Dhanani, The University of Texas Health Science Center, Houston
- Investigators
- Nadeem N Dhanani, MD MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340650
- Sponsor's protocol ID
- HSC-MS-14-0144
- Acronym
- HRME_Bladder
- Status last verified
- Jun 2021
- First submitted
- 13 Jan 2015
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Imaging for Early and Better Detection of Bladder Cancer
- ClinicalTrials.gov ID
- NCT02340650
- Acronym / sponsor ID
- HRME_Bladder / HSC-MS-14-0144
- Conditions
- Bladder Cancer
- Keywords
- suspicious bladder lesion, normal bladder tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- William Marsh Rice University
- Study start
- Apr 2015 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patients | – | Device: Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution MicroendoscopeHigh resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution MicroendoscopeAlso: HRME and/or LSC-HRME | Device | Bladder Cancer Patients |
Primary outcome
Specificity of Bladder Cancer Detection Imaging
Time frame: baseline (at the time of imaging)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Derived from this study: PubMed 33307957Tang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadeem N Dhanani, MD MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of Bladder Cancer Detection Imaging (time frame: baseline (at the time of imaging)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.