Laryngeal DysplasiaNCT02628496
Confocal Laser Microlaryngoscopy (CLMx)
A study testing Fluorescein injection, USP 10% and Confocal laser microlaryngoscopy in people with Laryngeal Dysplasia and Laryngeal Neoplasm, run by Washington University School of Medicine.
Trial summary
The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Dysplasia, Laryngeal Neoplasm
- What is being tested?
- Fluorescein injection, USP 10% and Confocal laser microlaryngoscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2017
- 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
- Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
- Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Patient must not have a history of radiation to the neck.
- Patient must not have a documented reaction to fluorescein
- Patient must not have a previous history of laryngeal cancer.
- Patient must not have a history of allergy or bronchial asthma.
- Patient must not be pregnant or breastfeeding.
About this study
Official title: Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.
In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.
- Conditions
- Laryngeal Dysplasia, Laryngeal Neoplasm
- Being tested
- Fluorescein injection, USP 10%, Confocal laser microlaryngoscopy, Biopsy (standard of care), KTP laser photoablation (standard of care)
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein injection, USP 10%Drug
Also called AK-FLUOR
-2.5 ml intravenous 10 minutes before procedure
Confocal laser microlaryngoscopyDevice
Also called CLM, CLMx
Biopsy (standard of care)Procedure or surgery
KTP laser photoablation (standard of care)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CLM | Experimental | * On the day of surgery, participants will have placement of laser-safe endotracheal tube and a rigid laryngoscope will be introduced into the oral cavity to gain access to the laryngeal introitus and then placed into suspension (standard of care)
* Fluorescein dye will be administered intravenously
* Confocal laser probe will be introduced through the rigid laryngoscope and touched first on the lesion of concern and put into scanning mode in order to obtain photos and video footage of the lesions. The probe will then be placed on normal appearing vocal fold tissue to obtain a control sample.
* The remainder of the procedure is standard excisional biopsy and KTP laser photoablation Receives: Drug: Fluorescein injection, USP 10%; Device: Confocal laser microlaryngoscopy; Procedure: Biopsy (standard of care); Procedure: KTP laser photoablation (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
Measured: Day of surgery (Day 1)
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
Measured: Day of surgery (Day 1)
Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
-If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity*Prevalence + Specificity*(1-Prevalence)
Measured: Day of surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Lost funding/staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DysplasiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Bradley, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628496
- Sponsor's protocol ID
- 201503127
- Status last verified
- Sep 2016
- First submitted
- 9 Dec 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Microlaryngoscopy (CLMx): A Novel Tool for Noninvasive Evaluation of Laryngeal Lesions
- ClinicalTrials.gov ID
- NCT02628496
- Acronym / sponsor ID
- 201503127
- Conditions
- Laryngeal Dysplasia, Laryngeal Neoplasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost funding/staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 11 Dec 2015 (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.
The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.
In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CLM | Experimental | Drug: Fluorescein injection, USP 10%, Device: Confocal laser microlaryngoscopy, Procedure: Biopsy (standard of care), Procedure: KTP laser photoablation (standard of care)* On the day of surgery, participants will have placement of laser-safe endotracheal tube and a rigid laryngoscope will be introduced into the oral cavity to gain access to the laryngeal introitus and then placed into suspension (standard of care) * Fluorescein dye will be administered intravenously * Confocal laser probe will be introduced through the rigid laryngoscope and touched first on the lesion of concern and put into scanning mode in order to obtain photos and video footage of the lesions. The probe will then be placed on normal appearing vocal fold tissue to obtain a control sample. * The remainder of the procedure is standard excisional biopsy and KTP laser photoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
- Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Key exclusion criteria (5 listed)
- Patient must not have a history of radiation to the neck.
- Patient must not have a documented reaction to fluorescein
- Patient must not have a previous history of laryngeal cancer.
- Patient must not have a history of allergy or bronchial asthma.
- Patient must not be pregnant or breastfeeding.
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 |
|---|---|---|
| Fluorescein injection, USP 10%Also: AK-FLUOR-2.5 ml intravenous 10 minutes before procedure | Drug | Arm 1: CLM |
| Confocal laser microlaryngoscopyAlso: CLM, CLMx | Device | Arm 1: CLM |
| Biopsy (standard of care) | Procedure or surgery | Arm 1: CLM |
| KTP laser photoablation (standard of care) | Procedure or surgery | Arm 1: CLM |
Primary outcome
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
Time frame: Day of surgery (Day 1)
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
Time frame: Day of surgery (Day 1)
Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
Time frame: Day of surgery (Day 1)
-If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity*Prevalence + Specificity*(1-Prevalence)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Joseph Bradley, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescein injection, USP 10% and Confocal laser microlaryngoscopy in people with Laryngeal Dysplasia and Laryngeal Neoplasm, run by Washington University School of Medicine.
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 5 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: withdrawn, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe (time frame: Day of surgery (Day 1)). The study lists 3 primary outcomes in all. 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 Sep 2016.