Barrett's Esophagus With or Without DysplasiaOCTNCT00579748
Optical Coherence Tomography of the Gastrointestinal Tract
An observational study of Barrett's Esophagus With or Without Dysplasia and Patients With Early Esophageal or Gastric Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus With or Without Dysplasia, Patients With Early Esophageal or Gastric Cancer, Patients With Intestinal Metaplasia of the Stomach
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2007
- 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: This study will involve the OCT imaging of patients undergoing endoscopy of the upper digestive tract in the gastrointestinal endoscopy suite in the H. H. Chao Digestive Diseases Center (CDDC) at UC Irvine Medical Center. These patients will include: 1) patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR) 2) patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy or 3) patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.
Who may be able to join
- Patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR).
- Patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy. These cancers must be limited to T1 N0 M0 (tumor invades submucosa with no lymph node involvement and no metastasis) according to the American Joint Committee on Cancer (AJC) Guidelines (1988 or later). Tumors may either be adenocarcinoma or squamous cell cancers. EUS and CT scanning will be required to confirm tumor staging. Tumors must be limited only to the mucosa or submucosa when examined by high frequency c-EUS. Any thickness of tumor lesion is acceptable provided the lesion does not appear to reach the muscularis propria.
- Patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.
- Patients must be at least 18 years of age. Female patients must not be pregnant (must have a negative serum pregnancy test) or nursing, and must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
- Patients must sign an informed consent.
Who cannot join
- Patients with esophageal or gastric cancer, who have tumor extension into the muscularis propria on endoscopic ultrasonography (EUS) (i.e. tumor depth of invasion T2 or greater).
- Patients with esophageal strictures unresponsive to dilation.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with inability to understand or carry out instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially available for eye and skin use, and several clinical reports on the use of OCT in the gastrointestinal tract have been published as well.
The purpose of this study is to develop a high-speed noninvasive OCT probe which can be placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in the gastrointestinal tract. This is a pilot clinical research study that is designed to advance OCT technology, which may in the future be able to replace or augment endoscopic biopsies.
Read the detailed description
Protocol Summary The long term objective of the proposed research is to develop a high-speed noninvasive endoscopic functional optical coherence tomography (F-OCT) device using microelectromechanical system (MEMS) technology for early diagnosis of tumors or lesions in gastrointestinal tracts.
Study Design All patients undergoing endoscopy at UCIMC CDDC and who meet eligibility criteria will be candidates for enrollment in the protocol. Signed informed consent will be obtained.
Standard of Care Procedure The patients will undergo the standard of care endoscopy. Endoscopy is performed on a routine basis with conscious sedation or general anesthesia. Digital images and video clips of the areas of interest will be captured in the usual standard of care fashion.
Research Procedure The OCT probe will then be inserted through the biopsy channel of the endoscope into the GI tract lumen and OCT images will be acquired of the lesions just prior to biopsies (research procedure). In addition, OCT images will be taken of the surrounding normal tissue.
Primary Endpoint The OCT images will be correlated to the specific biopsy site and biopsy number.
OCT Device and Probe Optical coherence tomography (OCT) is an emerging imaging modality that uses light to image turbid media such as living tissues, and has been successfully used to generate high resolution (~10 micron) cross-sectional images of tissue microstructure in the human retina and skin. OCT devices are now commercially available for ophthalmic and dermatologic use, and several clinical reports on the use of OCT in the vascular system and aerodigestive tract have been published as well.
The OCT device is an optical imaging instrument that combines a broadband low power near infrared light source (non-laser) with an interferometer to produce cross-sectional optical images of tissue to depths of 1-2 mm. OCT is already used commercially to image the retina and skin. This study focuses on a device designed specifically for the aerodigestive tract. The OCT probe has been designed to fit through the biopsy channel of standard endoscopes. The probes are designed with three different types of mechanism. (1) The first mechanism consists of a fiber optic with a micro lens and prism attached at the end to direct the light to and from the tissue sample. Scanning is achieved by moving the fiber optic along its axis using a linear motor. Longitudinal OCT imaging can be realized with this mechanism. Similar probes are already used in our laryngoscopic OCT study. (2) The second mechanism is achieved by a rotational MEMS motor, on which an angled mirror is attached to direct the light to the side. Rotational imaging can be realized with this mechanism. (3) The third mechanism is based on the silicon MEMS technology. The scanner is created with a polysilicon micromirror driven by high frequency, thick single crystal silicon comb drives. The high speed scanning probe is with large scan angles, excellent optical properties, high precision, and long-term reliability. The overall cross-sectional diameter is approximately 3 mm to be able to fit into the biopsy channel of the endoscope. The OCT device will focus the incident low-coherence light onto the tissue and collect backscattered coherent photons. The endoscopists can then obtain cross sectional optical images of the tissue through arbitrary planes of section.
- Conditions
- Barrett's Esophagus With or Without Dysplasia, Patients With Early Esophageal or Gastric Cancer, Patients With Intestinal Metaplasia of the Stomach
- Keywords
- OCT imaging, Barrett's esophagus
- Medical subject headings
- Stomach Neoplasms, Barrett Esophagus
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The OCT images will be correlated to the specific biopsy site and biopsy number.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJun 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus With or Without DysplasiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth J Chang, MD, Principal investigator, University of California, IrvineZhongping Chen, Ph.D., Study director, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579748
- Sponsor's protocol ID
- HS# 2005-4314
- Other IDs
- Award Number: CA-91717, Proposal Number: 30011
- Acronym
- OCT
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2007
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00579748
- Acronym / sponsor ID
- OCT / HS# 2005-4314
- Conditions
- Barrett's Esophagus With or Without Dysplasia, Patients With Early Esophageal or Gastric Cancer, Patients With Intestinal Metaplasia of the Stomach
- Keywords
- OCT imaging, Barrett's esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Dec 2007 (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.
Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially available for eye and skin use, and several clinical reports on the use of OCT in the gastrointestinal tract have been published as well.
The purpose of this study is to develop a high-speed noninvasive OCT probe which can be placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in the gastrointestinal tract. This is a pilot clinical research study that is designed to advance OCT technology, which may in the future be able to replace or augment endoscopic biopsies.
Detailed description
Protocol Summary The long term objective of the proposed research is to develop a high-speed noninvasive endoscopic functional optical coherence tomography (F-OCT) device using microelectromechanical system (MEMS) technology for early diagnosis of tumors or lesions in gastrointestinal tracts.
Study Design All patients undergoing endoscopy at UCIMC CDDC and who meet eligibility criteria will be candidates for enrollment in the protocol. Signed informed consent will be obtained.
Standard of Care Procedure The patients will undergo the standard of care endoscopy. Endoscopy is performed on a routine basis with conscious sedation or general anesthesia. Digital images and video clips of the areas of interest will be captured in the usual standard of care fashion.
Research Procedure The OCT probe will then be inserted through the biopsy channel of the endoscope into the GI tract lumen and OCT images will be acquired of the lesions just prior to biopsies (research procedure). In addition, OCT images will be taken of the surrounding normal tissue.
Primary Endpoint The OCT images will be correlated to the specific biopsy site and biopsy number.
OCT Device and Probe Optical coherence tomography (OCT) is an emerging imaging modality that uses light to image turbid media such as living tissues, and has been successfully used to generate high resolution (~10 micron) cross-sectional images of tissue microstructure in the human retina and skin. OCT devices are now commercially available for ophthalmic and dermatologic use, and several clinical reports on the use of OCT in the vascular system and aerodigestive tract have been published as well.
The OCT device is an optical imaging instrument that combines a broadband low power near infrared light source (non-laser) with an interferometer to produce cross-sectional optical images of tissue to depths of 1-2 mm. OCT is already used commercially to image the retina and skin. This study focuses on a device designed specifically for the aerodigestive tract. The OCT probe has been designed to fit through the biopsy channel of standard endoscopes. The probes are designed with three different types of mechanism. (1) The first mechanism consists of a fiber optic with a micro lens and prism attached at the end to direct the light to and from the tissue sample. Scanning is achieved by moving the fiber optic along its axis using a linear motor. Longitudinal OCT imaging can be realized with this mechanism. Similar probes are already used in our laryngoscopic OCT study. (2) The second mechanism is achieved by a rotational MEMS motor, on which an angled mirror is attached to direct the light to the side. Rotational imaging can be realized with this mechanism. (3) The third mechanism is based on the silicon MEMS technology. The scanner is created with a polysilicon micromirror driven by high frequency, thick single crystal silicon comb drives. The high speed scanning probe is with large scan angles, excellent optical properties, high precision, and long-term reliability. The overall cross-sectional diameter is approximately 3 mm to be able to fit into the biopsy channel of the endoscope. The OCT device will focus the incident low-coherence light onto the tissue and collect backscattered coherent photons. The endoscopists can then obtain cross sectional optical images of the tissue through arbitrary planes of section.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve the OCT imaging of patients undergoing endoscopy of the upper digestive tract in the gastrointestinal endoscopy suite in the H. H. Chao Digestive Diseases Center (CDDC) at UC Irvine Medical Center. These patients will include: 1) patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR) 2) patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy or 3) patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.
Key inclusion criteria (5 listed)
- Patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR).
- Patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy. These cancers must be limited to T1 N0 M0 (tumor invades submucosa with no lymph node involvement and no metastasis) according to the American Joint Committee on Cancer (AJC) Guidelines (1988 or later). Tumors may either be adenocarcinoma or squamous cell cancers. EUS and CT scanning will be required to confirm tumor staging. Tumors must be limited only to the mucosa or submucosa when examined by high frequency c-EUS. Any thickness of tumor lesion is acceptable provided the lesion does not appear to reach the muscularis propria.
- Patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.
- Patients must be at least 18 years of age. Female patients must not be pregnant (must have a negative serum pregnancy test) or nursing, and must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
- Patients must sign an informed consent.
Key exclusion criteria (4 listed)
- Patients with esophageal or gastric cancer, who have tumor extension into the muscularis propria on endoscopic ultrasonography (EUS) (i.e. tumor depth of invasion T2 or greater).
- Patients with esophageal strictures unresponsive to dilation.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with inability to understand or carry out instructions.
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
The OCT images will be correlated to the specific biopsy site and biopsy number.
Time frame: 1 hour
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 9 Apr 2021.
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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.
Kenneth J Chang, MD principal investigator
University of California, Irvine
Zhongping Chen, Ph.D. study director
University of California, Irvine
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 Barrett's Esophagus With or Without Dysplasia and Patients With Early Esophageal or Gastric Cancer, run by University of California, Irvine 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 5 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 9 Apr 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?
The OCT images will be correlated to the specific biopsy site and biopsy number. (time frame: 1 hour). 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 9 Apr 2021.