Nasopharyngeal CarcinomaNCT03202173
The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
A study testing 10% fluorescein in people with Nasopharyngeal Carcinoma and Squamous Cell Carcinoma of the Head and Neck, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- 10% fluorescein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Jun 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years of age
- Indicated for nasal endoscope for indeterminate NPC
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Who cannot join
- Subjects for whom pCLE procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Trial locations and contacts
1 site in 1 country.
Huawei Li, Phd &MD contact
Lingjie Wu, MS & MD contact
China1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
Huawei Li, Phd &MD, hwli@shmu.edu.cn
Lingjie Wu, MS &MD, wulingjie116@163.com
About this study
Official title: The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
Read the detailed description
The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.
- Being tested
- 10% fluorescein
- Keywords
- Probe-based confocal laser endomicroscopy, Optical biopsy
- Medical subject headings
- Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% fluoresceinDiagnostic test
The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.
| Study group | Role | What they receive |
|---|---|---|
| normal mucosa | Active comparator | 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: 10% fluorescein |
| lymphoid hyperplasia | Experimental | 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 nasopharyngeal mucosa after intravenous injecting 10% fluorescein.. Receives: Diagnostic Test: 10% fluorescein |
| nasopharyngeal carcinoma | Experimental | pCLE images of nasopharyngeal carcinoma, which was 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: 10% fluorescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCLE classification and scoring system
Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.
Measured: 3 months
Secondary outcomes (1)
the quantitative image analysis
Quantitative image features are calculated in the pCLE images
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2017
- Primary completion27 Dec 2017
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huawei Li, Ph.D, MD, Eye & ENT Hospital of Fudan University
- Investigators
- Huawei Li, Phd &MD, Study chair, Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202173
- Sponsor's protocol ID
- pCLE in the diagnosis of NPC
- Status last verified
- Jan 2018
- First submitted
- 27 Jun 2017
- Last updated
- 5 Feb 2018
- 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 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT03202173
- Acronym / sponsor ID
- pCLE in the diagnosis of NPC
- Keywords
- Probe-based confocal laser endomicroscopy, Optical biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 28 Jun 2017 (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 use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
Detailed description
The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal mucosa | Active comparator | Diagnostic Test: 10% fluoresceinFlat 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. |
| lymphoid hyperplasia | Experimental | Diagnostic Test: 10% fluoresceinAn 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 nasopharyngeal mucosa after intravenous injecting 10% fluorescein.. |
| nasopharyngeal carcinoma | Experimental | Diagnostic Test: 10% fluoresceinpCLE images of nasopharyngeal carcinoma, which was 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
Key inclusion criteria (3 listed)
- Male or female > 18 years of age
- Indicated for nasal endoscope for indeterminate NPC
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Subjects for whom pCLE procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
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 |
|---|---|---|
| 10% fluoresceinThe nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract. | Diagnostic test | lymphoid hyperplasia, nasopharyngeal carcinoma, normal mucosa |
Primary outcome
pCLE classification and scoring system
Time frame: 3 months
Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.
1 secondary outcome
the quantitative image analysis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Huawei Li, Phd &MD contact
Lingjie Wu, MS & MD contact
Huawei Li, Phd &MD study chair
Otorhinolaryngology Department of Affiliated Eye and 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?
A study testing 10% fluorescein in people with Nasopharyngeal Carcinoma and Squamous Cell Carcinoma of the Head and Neck, 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 3 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 5 Feb 2018. 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 Huawei Li, Phd &MD (hwli@shmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCLE classification and scoring system (time frame: 3 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 5 Feb 2018.