Primary Ciliary DyskinesiaNCT02699177
In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry
An observational study of Primary Ciliary Dyskinesia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
1. Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients. 2. Assessments of the effect of drugs and other therapies on CBF using the study system. 3. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Ciliary Dyskinesia
- What is being tested?
- CBF measurements
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Jul 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with suspected PCD
Who may be able to join
- Patients referred for Ciliary Brush Biopsy
Who cannot join
- Active nasal bleeding
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91240
David Shoseyov, MD, 972-2-5844430/1, shoseyov@hadassah.org.il
Reuven Tzabari, MD
About this study
- Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients.
- Assessments of the effect of drugs and other therapies on CBF using the study system.
- Comparison of results with standard methods such as ciliary brush biopsies
Read the detailed description
Background Mucociliary clearance of the airways depends on ciliary movement by ciliated cells that cover the entire airway and the sinuses. In many airway diseases the mucociliary clearance is affected by injury caused by smoke, viruses, other infectious organisms or genetic diseases that are called Primary Ciliary Dyskinesia (PCD).
The diagnosis of PCD is based on a combination of clinical findings such as bronchiectasis, chronic sinusitis, chronic otitis media and immotile sperms.
In addition, in tests performed in the pulmonary laboratory nasal nitric oxide levels may be low.
Samples obtained by nasal brush biopsy can be analyzed and the ciliary movement recorded by video microscopy. Ciliary beat frequency (CBF) can be calculated in freshly isolated samples but also after growing the tissue in cell culture.
Furthermore, ciliated cells can be analyzed by electron microscopy to detect defects in the microscopic structure of the cilia.
The major problem encountered by all these assays is that they are performed under in vitro conditions and not in the natural environment of the cells where the acidity (pH), temperature, electrolytes etc. may be very different.
Moreover, genetic testing is limited to mutations known to cause PCD, ruling out mutations not yet discovered.
Therefore a method is needed to unequivocally measure ciliary movement in the natural environment.
Goal
- Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients.
- Assessments of the effect of drugs and other therapies on CBF using the study system.
Methods The protocol has been approved by the local Institutional Review Board (IRB) of the Hadassah Medical Center, Jerusalem, Israel
Equipment:
- High Speed High Video Microscope built to specifications needed for this study based on a commercially available high speed video system.
- The green light source (LED) used consists of a spot of 3mm diameter and has an energy of 10 milli Watt ( equal to 1Kilowatt/square meter)
- Video camera (manufactured by SONY Inc, Japan)
Patients:
Patients referred for ciliary brush biopsy will be asked to sign the informed consent and to be enrolled into the study.
Patients will be examined by having a high speed digital video camera placed close to the nasal cavity in order to photograph the area of interest. The camera lens will be off focus and the reflected light from the nasal mucosa will be recorded. This reflected light recording will be analyzed to obtain the CBF, heart rate and respiratory rate.
After the recording the patient will proceed to the nasal brush ciliary biopsy. The cells will be analyzed by a CBF will be calculated from several areas of the smear.
Safety measures:
All participating patients will wear a protective cover over their eyes during photography.
- Conditions
- Primary Ciliary Dyskinesia
- Being tested
- CBF measurements
- Keywords
- ciliary beat frequency,
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBF measurementsDevice
Also called Ciliary brush biopsy
CBF measurements
| Study group | Role | What they receive |
|---|---|---|
| Suspected PCD but negative | CBF measurements:
1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI.
2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF.
3. The two methods will be compared. Receives: Device: CBF measurements | |
| Suspected PCD but positive | CBF measurements:
1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI.
2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF.
3. The two methods will be compared. Receives: Device: CBF measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ciliary beat frequency (CBF) measured by high speed video microscopy
Ex vivo measurements of CBF analysing high speed video records of nasal brush biopsies
Measured: 5 minutes
Ciliary beat frequency (CBF) measured by interferometry
In vivo measurements of CBF analysing the reflected light from the nasal cavity
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHOSEYOV DAVID, Hadassah Medical Organization
- Investigators
- David Shoseyov, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699177
- Sponsor's protocol ID
- 0366-15-HMO-CTIL
- Status last verified
- Feb 2016
- First submitted
- 29 Dec 2015
- Last updated
- 4 Mar 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 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry
- ClinicalTrials.gov ID
- NCT02699177
- Acronym / sponsor ID
- 0366-15-HMO-CTIL
- Conditions
- Primary Ciliary Dyskinesia
- Keywords
- ciliary beat frequency,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 4 Mar 2016 (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.
- Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients.
- Assessments of the effect of drugs and other therapies on CBF using the study system.
- Comparison of results with standard methods such as ciliary brush biopsies
Detailed description
Background Mucociliary clearance of the airways depends on ciliary movement by ciliated cells that cover the entire airway and the sinuses. In many airway diseases the mucociliary clearance is affected by injury caused by smoke, viruses, other infectious organisms or genetic diseases that are called Primary Ciliary Dyskinesia (PCD).
The diagnosis of PCD is based on a combination of clinical findings such as bronchiectasis, chronic sinusitis, chronic otitis media and immotile sperms.
In addition, in tests performed in the pulmonary laboratory nasal nitric oxide levels may be low.
Samples obtained by nasal brush biopsy can be analyzed and the ciliary movement recorded by video microscopy. Ciliary beat frequency (CBF) can be calculated in freshly isolated samples but also after growing the tissue in cell culture.
Furthermore, ciliated cells can be analyzed by electron microscopy to detect defects in the microscopic structure of the cilia.
The major problem encountered by all these assays is that they are performed under in vitro conditions and not in the natural environment of the cells where the acidity (pH), temperature, electrolytes etc. may be very different.
Moreover, genetic testing is limited to mutations known to cause PCD, ruling out mutations not yet discovered.
Therefore a method is needed to unequivocally measure ciliary movement in the natural environment.
Goal
- Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients.
- Assessments of the effect of drugs and other therapies on CBF using the study system.
Methods The protocol has been approved by the local Institutional Review Board (IRB) of the Hadassah Medical Center, Jerusalem, Israel
Equipment:
- High Speed High Video Microscope built to specifications needed for this study based on a commercially available high speed video system.
- The green light source (LED) used consists of a spot of 3mm diameter and has an energy of 10 milli Watt ( equal to 1Kilowatt/square meter)
- Video camera (manufactured by SONY Inc, Japan)
Patients:
Patients referred for ciliary brush biopsy will be asked to sign the informed consent and to be enrolled into the study.
Patients will be examined by having a high speed digital video camera placed close to the nasal cavity in order to photograph the area of interest. The camera lens will be off focus and the reflected light from the nasal mucosa will be recorded. This reflected light recording will be analyzed to obtain the CBF, heart rate and respiratory rate.
After the recording the patient will proceed to the nasal brush ciliary biopsy. The cells will be analyzed by a CBF will be calculated from several areas of the smear.
Safety measures:
All participating patients will wear a protective cover over their eyes during photography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected PCD but negative | – | Device: CBF measurementsCBF measurements: 1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI. 2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF. 3. The two methods will be compared. |
| Suspected PCD but positive | – | Device: CBF measurementsCBF measurements: 1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI. 2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF. 3. The two methods will be compared. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with suspected PCD
Key inclusion criteria (1 listed)
- Patients referred for Ciliary Brush Biopsy
Key exclusion criteria (1 listed)
- Active nasal bleeding
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 |
|---|---|---|
| CBF measurementsAlso: Ciliary brush biopsyCBF measurements | Device | Suspected PCD but negative, Suspected PCD but positive |
Primary outcome
Ciliary beat frequency (CBF) measured by high speed video microscopy
Time frame: 5 minutes
Ex vivo measurements of CBF analysing high speed video records of nasal brush biopsies
Ciliary beat frequency (CBF) measured by interferometry
Time frame: 5 minutes
In vivo measurements of CBF analysing the reflected light from the nasal cavity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- 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.
David Shoseyov, MD principal investigator
Hadassah Medical Organization
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 Primary Ciliary Dyskinesia, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2016. 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 Israel. 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 David Shoseyov, MD (972-507874091, shoseyov@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ciliary beat frequency (CBF) measured by high speed video microscopy (time frame: 5 minutes). The study lists 2 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 4 Mar 2016.