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Gastrointestinal NeoplasmsNCT04670718

The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract

A study testing Optical Coherence Tomography Probe in people with Gastrointestinal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study aiming to investigate the ability of a novel Optical Coherence Tomography (OCT) probe in assessing the different layers of the gastrointestinal tract and the depth of invasion of early neoplasia, utilising surgically and endoscopically resected specimens Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Neoplasms
What is being tested?
Optical Coherence Tomography Probe
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteHong Kong
Study dates
10 Dec 2020to 30 Jun 2021
Phase
Interventional
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

Who may be able to join

  • Patients with esophageal, gastric or colonic cancer undergoing elective surgical resection
  • Patients with early esophageal, gastric or colonic neoplasia undergoing endoscopic resection (Endoscopic submucosal dissection)

Who cannot join

  • Refusal to participate

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Use of a Novel Optical Coherence Tomography (OCT) Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal Tract

This is a pilot study aiming to investigate the ability of a novel Optical Coherence Tomography (OCT) probe in assessing the different layers of the gastrointestinal tract and the depth of invasion of early neoplasia, utilising surgically and endoscopically resected specimens

Read the detailed description

Endoscopic treatment of early neoplasia in the gastrointestinal tract has been established as the standard therapy in the past decade. Various endoscopic resection techniques have been developed, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), to ensure complete removal of such lesions and avoid recurrence. Successful endoscopic resection of early gastrointestinal (GI) neoplasia relies on accurate pre-procedural prediction of the margin and depth of invasion of the corresponding lesions. Generally, GI neoplasia (even carcinoma) confined to the mucosa layer could be safely removed endoscopically with margin negative resection and minimal chance of lymph node involvement.

Image-enhanced endoscopy or endoscopic ultrasonography has been used as the modality of pre-resection assessment on the depth of invasion. Chromoendoscopy and digital enhancement such as magnifying Narrow Band Imaging (NBI) focus on characterization of the surface morphology and the vascular structures and predict the depth of invasion instead of direct depth measurement. Endoscopic ultrasonography allows good visualization of the different layers of GI tract, but the ability to differentiate early mucosal (T1a) or submucosal invasive (T1b) cancer remains limited owing to its low resolution (>100um). A small proportion of patients subjected for endoscopic resection had invasive cancer not curable by endoscopic means and require additional surgery afterwards. There is thus a potential role for further refinement of imaging technique to allow better prediction of tumor depth in early GI neoplasia.

Optical coherence tomography (OCT) is a novel high spatial-resolution, cross-sectional imaging technique that allows visualization of biological tissue at higher resolution (~10um). It has been used routinely in the field of ophthalmology for retinal assessment. Earlier studies have also confirmed the potential application in the gastrointestinal tract with a probe-based design to be placed within an endoscopy.

The Department of Mechanical and Automation Engineering from the Chinese University of Hong Kong have recently designed a novel OCT probe that could be placed within the working channel of an endoscope. In-vitro experiment with porcine intestinal model demonstrated its ability to provide high-resolution images with visualization of different layers of the GI tract. The investigators therefore design this pilot study to assess the application of the OCT probe in human resected tissue specimen to assess the ability in determining different layers of GI tract and depth of invasion of GI tumors.

The current pilot study is designed aiming to assess the ability of the novel OCT probe in visualization of the layers of the human GI tract and depth of invasion of GI neoplasia in resected surgical and endoscopic specimens. There would be two parts of the study:

  1. To visualize normal gastrointestinal tract in a resected surgical specimen of esophageal, stomach, small bowel and colonic tissue.
  2. To assess the depth of invasion of the neoplastic tissue in surgical specimens as well as endoscopic (ESD) specimens
Being tested
Optical Coherence Tomography Probe
Keywords
Gastrointestinal neoplasm, Optical coherence tomography
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence Tomography ProbeDevice

    Use of OCT probe for examination of gastrointestinal tract

Study groups in NCT04670718
Study groupRoleWhat they receive
OCT probeExperimentalThe examination of gastrointestinal tract resected specimen with the use of the OCT probe
Receives: Device: Optical Coherence Tomography Probe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visualisation of gastrointestinal tract

    Visualisation of different layers of gastrointestinal tract. Ability to differentiate mucosa and submucosa and muscular propria layer. (Yes or No).

    Measured: 1 day

Secondary outcomes (1)
  1. Ability to asses depth of invasion of resected GI early tumor

    Ability to assess depth of invasion of resected GI early tumor

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start10 Dec 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670718
Sponsor's protocol ID
2020.570
Status last verified
Jul 2021
First submitted
11 Dec 2020
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Optical Coherence Tomography Probe in people with Gastrointestinal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 2 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 28 Jul 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 Hong Kong. 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?

Visualisation of gastrointestinal tract (time frame: 1 day). 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 28 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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