Bladder CancerPhase 1MPMNCT00652210
Use of Multiphoton Microscopy in the Diagnosis of Cancer
A Phase 1 study testing Multiphoton microscopy in people with Bladder Cancer and Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Prostate Cancer
- What is being tested?
- Multiphoton microscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2015
- Phase
- Phase 1
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anyone who presents with bladder and/or prostate cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. After development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. After exhibiting usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the colon.
Read the detailed description
Same as above
- Conditions
- Bladder Cancer, Prostate Cancer
- Being tested
- Multiphoton microscopy
- Keywords
- Bladder cancer, prostate cancer, multiphoton microscopy
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiphoton microscopyOther
Use of multiphoton microscopy to diagnose cancer
| Study group | Role | What they receive |
|---|---|---|
| MPM | Experimental | Subject tissue was reviewed using multiphoton microscopy Receives: Other: Multiphoton microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred.
Measured: 10/14/2007 to 2/15/2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJun 2005
- Primary completionSep 2015
- Study completionSep 2015
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 Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas S. Scherr, Weill Medical College of Cornell University
- Investigators
- Douglas S Scherr, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652210
- Sponsor's protocol ID
- 0506007919
- Acronym
- MPM
- Status last verified
- Dec 2015
- First submitted
- 31 Mar 2008
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Multiphoton Microscopy in the Diagnosis of Cancer
- ClinicalTrials.gov ID
- NCT00652210
- Acronym / sponsor ID
- MPM / 0506007919
- Conditions
- Bladder Cancer, Prostate Cancer
- Keywords
- Bladder cancer, prostate cancer, multiphoton microscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Apr 2008 (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.
Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. After development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. After exhibiting usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the colon.
Detailed description
Same as above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPM | Experimental | Other: Multiphoton microscopySubject tissue was reviewed using multiphoton microscopy |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone who presents with bladder and/or prostate cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multiphoton microscopyUse of multiphoton microscopy to diagnose cancer | Other | MPM |
Primary outcome
After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred.
Time frame: 10/14/2007 to 2/15/2008
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 10 Dec 2015.
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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.
Douglas S Scherr, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multiphoton microscopy in people with Bladder Cancer and Prostate Cancer, run by Weill Medical College of Cornell University 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 1 inclusion and 0 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 10 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred. (time frame: 10/14/2007 to 2/15/2008). 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 10 Dec 2015.