Laryngeal LeiomyomaNCT04139889
Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy
An observational study of Laryngeal Leiomyoma and Probe-based Confocal Laser Endomicroscopy, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Laryngeal Leiomyoma, Probe-based Confocal Laser Endomicroscopy
- What is being tested?
- Confocal Laser Endomicroscopy
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 21 Dec 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.
Who may be able to join
- 18≤Male or female age ≤85 years old;
- patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
- Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Who cannot join
- Male or female <18 years old, or Male or female >85 years;
- The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
- The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
- The patient has a history of allergies to drugs or food.
- The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
- Lactation or pregnant women.
- Refusal to sign the informed consent form.
- Others who do not take this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Lingjie Wu
About this study
Official title: The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo
To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.
Read the detailed description
In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.
- Being tested
- Confocal Laser Endomicroscopy
- Keywords
- Probe-based confocal laser endomicroscopy, Optical biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser EndomicroscopyDiagnostic test
Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm.
| Study group | Role | What they receive |
|---|---|---|
| normal mucosa | Flat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein. Receives: Diagnostic Test: Confocal Laser Endomicroscopy | |
| non-malignant lesions | An unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of non-malignant lesions after intravenous injecting 10% fluorescein. Receives: Diagnostic Test: Confocal Laser Endomicroscopy | |
| malignant lesions | pCLE images of malignant lesions were associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein. Receives: Diagnostic Test: Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCLE diagnostic classification
Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.
Measured: 6 months
Secondary outcomes (1)
the image analysis by machine learning
Quantitative image features are calculated in the pCLE images by machine learning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Jun 2017
- Primary completion30 Nov 2019
- Study completion21 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal LeiomyomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, PhD &MD, Study chair, Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139889
- Sponsor's protocol ID
- 20170601
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo
- ClinicalTrials.gov ID
- NCT04139889
- Acronym / sponsor ID
- 20170601
- Keywords
- Probe-based confocal laser endomicroscopy, Optical biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- 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.
To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.
Detailed description
In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal mucosa | – | Diagnostic Test: Confocal Laser EndomicroscopyFlat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein. |
| non-malignant lesions | – | Diagnostic Test: Confocal Laser EndomicroscopyAn unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of non-malignant lesions after intravenous injecting 10% fluorescein. |
| malignant lesions | – | Diagnostic Test: Confocal Laser EndomicroscopypCLE images of malignant lesions were associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.
Key inclusion criteria (3 listed)
- 18≤Male or female age ≤85 years old;
- patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
- Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Male or female <18 years old, or Male or female >85 years;
- The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
- The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
- The patient has a history of allergies to drugs or food.
- The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
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 |
|---|---|---|
| Confocal Laser EndomicroscopyConfocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm. | Diagnostic test | malignant lesions, non-malignant lesions, normal mucosa |
Primary outcome
pCLE diagnostic classification
Time frame: 6 months
Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.
1 secondary outcome
the image analysis by machine learning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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.
Huawei Li, PhD &MD study chair
Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University
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 Laryngeal Leiomyoma and Probe-based Confocal Laser Endomicroscopy, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingjie Wu, PhD &MD (+86-15821574627, wulingjie116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCLE diagnostic classification (time frame: 6 months). 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 7 Jan 2020.