Bladder CancerNCT01810445
Endoscopic Subsurface Optical Imaging for Cancer Detection
An observational study of Bladder Cancer, run by University of California, Davis.
Trial summary
The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Aug 2011
- 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: Patients already scheduled to undergo a bladder surgery at UCDMC.
Who may be able to join
- Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center.
Who cannot join
- Non bladder surgical procedures at University of California Davis Medical Center.
About this study
The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.
Read the detailed description
This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Laser, Optical
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing a surgical bladder procedure in the main O.R. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure.
Does the subsurface laser allow enough light to visually assess the cells. Logical metric of either "Yes" or "No".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJan 1999
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stavros Demos, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810445
- Sponsor's protocol ID
- 200210092-9
- Other IDs
- Endoscopic Subsurface Study
- Status last verified
- Mar 2013
- First submitted
- 2 Aug 2011
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Subsurface Optical Imaging for Cancer Detection
- ClinicalTrials.gov ID
- NCT01810445
- Acronym / sponsor ID
- 200210092-9
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Laser, Optical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Mar 2013 (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 purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.
Detailed description
This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients undergoing a surgical bladder procedure in the main O.R. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already scheduled to undergo a bladder surgery at UCDMC.
Key inclusion criteria (1 listed)
- Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center.
Key exclusion criteria (1 listed)
- Non bladder surgical procedures at University of California Davis Medical Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure.
Time frame: 1 year
Does the subsurface laser allow enough light to visually assess the cells. Logical metric of either "Yes" or "No".
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 13 Mar 2013.
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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.
Stavros Demos, PhD principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of California, Davis.
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 1 inclusion and 1 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 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2013.