Gastrointestinal DiseasesNCT01034670
Advanced Gastrointestinal Endoscopic Imaging
A study testing Dual axis endoscopic microscope, wide field fluorescence system and CellVizio in people with Gastrointestinal Diseases and Gastric (Stomach) Cancer, run by Stanford University at 1 site in United States.
Trial summary
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)
- What is being tested?
- Dual axis endoscopic microscope, wide field fluorescence system and CellVizio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 25 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Either genders
- All ethnic backgrounds will be considered.
- Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study.
- The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
- Conditions
- Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)
- Being tested
- Dual axis endoscopic microscope, wide field fluorescence system, CellVizio, fluorescent Peptide, fluorescein
- Medical subject headings
- Gastrointestinal Diseases, Stomach Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual axis endoscopic microscopeDevice
Also called Stanford
This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.
wide field fluorescence systemDevice
Also called Olympus
This is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope.
CellVizioDevice
Also called Mauna Kea Technologies
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
fluorescent PeptideDrug
Also called GMP
microdosing; Topical through the endoscope
fluoresceinDrug
Also called fluorophore
100 mcg topical
indocyanine greenDrug
Also called ICG
100 mcg topical
| Study group | Role | What they receive |
|---|---|---|
| endoscopy arm | Experimental | imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. Receives: Device: Dual axis endoscopic microscope; Device: wide field fluorescence system; Device: CellVizio; Drug: fluorescent Peptide; Drug: fluorescein; Drug: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Imaging of the Mucosa
Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJun 2009
- Primary completion25 Sep 2017
- Study completion25 Sep 2017
Why it stopped: Change in personnel and cessation of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shai Friedland, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034670
- Sponsor's protocol ID
- IRB-15766
- Other IDs
- NCI-2021-03446, U54CA136465
- Status last verified
- May 2024
- First submitted
- 13 Nov 2009
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Gastrointestinal Endoscopic Imaging
- ClinicalTrials.gov ID
- NCT01034670
- Acronym / sponsor ID
- IRB-15766
- Conditions
- Gastrointestinal Diseases, Gastric (Stomach) Cancer, Gastrointestinal Stromal Tumor (GIST)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in personnel and cessation of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2009 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopy arm | Experimental | Device: Dual axis endoscopic microscope, Device: wide field fluorescence system, Device: CellVizio, Drug: fluorescent Peptide, Drug: fluorescein, Drug: indocyanine greenimaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Either genders
- All ethnic backgrounds will be considered.
- Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study.
- The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.
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 |
|---|---|---|
| Dual axis endoscopic microscopeAlso: StanfordThis is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa. | Device | endoscopy arm |
| wide field fluorescence systemAlso: OlympusThis is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope. | Device | endoscopy arm |
| CellVizioAlso: Mauna Kea TechnologiesMinimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols. | Device | endoscopy arm |
| fluorescent PeptideAlso: GMPmicrodosing; Topical through the endoscope | Drug | endoscopy arm |
| fluoresceinAlso: fluorophore100 mcg topical | Drug | endoscopy arm |
| indocyanine greenAlso: ICG100 mcg topical | Drug | endoscopy arm |
Primary outcome
Number of Participants With Successful Imaging of the Mucosa
Time frame: 5 years
Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shai Friedland principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual axis endoscopic microscope, wide field fluorescence system and CellVizio in people with Gastrointestinal Diseases and Gastric (Stomach) Cancer, run by Stanford 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 4 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: stopped early, as of the sponsor's last update on 26 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Imaging of the Mucosa (time frame: 5 years). 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 26 Jun 2024.