Lung CancerNWANCT00548730
Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy
An observational study of Lung Cancer, run by Antonios Likourezos at 1 site in United States.
Trial summary
The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2007to 31 May 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
Who may be able to join
- Patients with lung abnormalities that have an indication for bronchoscopy
Who cannot join
- Inability to tolerate bronchoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy
The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.
Read the detailed description
Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA).
Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images.
Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients.
Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study.
- Conditions
- Lung Cancer
- Being tested
- Bronchoscopy
- Keywords
- Bronchoscopy, Endoscopy, Image Enhancement, Autofluorescence, Narrow Band Image
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Also called AF bronchoscope (11004BI), NBI bronchoscope (BF-T180)
The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions.
| Study group | Role | What they receive |
|---|---|---|
| White Light Bronchoscopy | Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with white light bronchoscopy Receives: Procedure: Bronchoscopy | |
| Autofluorescence Bronchoscopy | Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with autofluorescence bronchoscopy Receives: Procedure: Bronchoscopy | |
| Narrow Band Imaged Bronchoscopy | Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with narrow band imaged bronchoscopy Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correlation between three different bronchoscopic images
Measured: One day
Secondary outcomes (1)
Elimination of false positives and negative bronchoscopic examinations for neoplasia
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study start1 Oct 2007
- Primary completion31 May 2009
- Study completion31 May 2009
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Joseph LoCicero, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548730
- Sponsor's protocol ID
- MMC07/06VA14
- Acronym
- NWA
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 2007
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
DaCosta RS, Wilson BC, Marcon NE. Light-induced fluorescence endoscopy of the gastrointestinal tract. Gastrointest Endosc Clin N Am. 2000 Jan;10(1):37-69, vi.
PubMed 10618453Gono K, Obi T, Yamaguchi M, Ohyama N, Machida H, Sano Y, Yoshida S, Hamamoto Y, Endo T. Appearance of enhanced tissue features in narrow-band endoscopic imaging. J Biomed Opt. 2004 May-Jun;9(3):568-77. doi: 10.1117/1.1695563.
PubMed 15189095Vincent BD, Fraig M, Silvestri GA. A pilot study of narrow-band imaging compared to white light bronchoscopy for evaluation of normal airways and premalignant and malignant airways disease. Chest. 2007 Jun;131(6):1794-9. doi: 10.1378/chest.06-2794. Epub 2007 May 15.
PubMed 17505042Lee P, Brokx HA, Postmus PE, Sutedja TG. Dual digital video-autofluorescence imaging for detection of pre-neoplastic lesions. Lung Cancer. 2007 Oct;58(1):44-9. doi: 10.1016/j.lungcan.2007.04.009. Epub 2007 May 29.
PubMed 17532537Ueno K, Kusunoki Y, Imamura F, Yoshimura M, Yamamoto S, Uchida J, Tsukamoto Y. Clinical experience with autofluorescence imaging system in patients with lung cancers and precancerous lesions. Respiration. 2007;74(3):304-8. doi: 10.1159/000093233. Epub 2006 May 5.
PubMed 16679756Jang TW, Oak CH, Chun BK, Jung MH. Detection of pre-invasive endobronchial tumors with D-light/autofluorescence system. J Korean Med Sci. 2006 Apr;21(2):242-6. doi: 10.3346/jkms.2006.21.2.242.
PubMed 16614508Haussinger K, Becker H, Stanzel F, Kreuzer A, Schmidt B, Strausz J, Cavaliere S, Herth F, Kohlhaufl M, Muller KM, Huber RM, Pichlmeier U, Bolliger ChT. Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial. Thorax. 2005 Jun;60(6):496-503. doi: 10.1136/thx.2005.041475.
PubMed 15923251
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy
- ClinicalTrials.gov ID
- NCT00548730
- Acronym / sponsor ID
- NWA / MMC07/06VA14
- Conditions
- Lung Cancer
- Keywords
- Bronchoscopy, Endoscopy, Image Enhancement, Autofluorescence, Narrow Band Image
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 31 May 2009 (actual)
- Study completion
- 31 May 2009 (actual)
- First posted
- 24 Oct 2007 (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 the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.
Detailed description
Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA).
Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images.
Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients.
Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White Light Bronchoscopy | – | Procedure: BronchoscopyPatients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with white light bronchoscopy |
| Autofluorescence Bronchoscopy | – | Procedure: BronchoscopyPatients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with autofluorescence bronchoscopy |
| Narrow Band Imaged Bronchoscopy | – | Procedure: BronchoscopyPatients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with narrow band imaged bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
Key inclusion criteria (1 listed)
- Patients with lung abnormalities that have an indication for bronchoscopy
Key exclusion criteria (1 listed)
- Inability to tolerate bronchoscopy
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 |
|---|---|---|
| BronchoscopyAlso: AF bronchoscope (11004BI), NBI bronchoscope (BF-T180)The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions. | Procedure or surgery | Autofluorescence Bronchoscopy, Narrow Band Imaged Bronchoscopy, White Light Bronchoscopy |
Primary outcome
Degree of correlation between three different bronchoscopic images
Time frame: One day
1 secondary outcome
Elimination of false positives and negative bronchoscopic examinations for neoplasia
Time frame: One day
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 11 Dec 2023.
- Background: PubMed 10618453DaCosta RS, Wilson BC, Marcon NE. Light-induced fluorescence endoscopy of the gastrointestinal tract. Gastrointest Endosc Clin N Am. 2000 Jan;10(1):37-69, vi.
- Background: PubMed 15189095Gono K, Obi T, Yamaguchi M, Ohyama N, Machida H, Sano Y, Yoshida S, Hamamoto Y, Endo T. Appearance of enhanced tissue features in narrow-band endoscopic imaging. J Biomed Opt. 2004 May-Jun;9(3):568-77. doi: 10.1117/1.1695563.
- Background: PubMed 17505042Vincent BD, Fraig M, Silvestri GA. A pilot study of narrow-band imaging compared to white light bronchoscopy for evaluation of normal airways and premalignant and malignant airways disease. Chest. 2007 Jun;131(6):1794-9. doi: 10.1378/chest.06-2794. Epub 2007 May 15.
- Background: PubMed 17532537Lee P, Brokx HA, Postmus PE, Sutedja TG. Dual digital video-autofluorescence imaging for detection of pre-neoplastic lesions. Lung Cancer. 2007 Oct;58(1):44-9. doi: 10.1016/j.lungcan.2007.04.009. Epub 2007 May 29.
- Background: PubMed 16679756Ueno K, Kusunoki Y, Imamura F, Yoshimura M, Yamamoto S, Uchida J, Tsukamoto Y. Clinical experience with autofluorescence imaging system in patients with lung cancers and precancerous lesions. Respiration. 2007;74(3):304-8. doi: 10.1159/000093233. Epub 2006 May 5.
- Background: PubMed 16614508Jang TW, Oak CH, Chun BK, Jung MH. Detection of pre-invasive endobronchial tumors with D-light/autofluorescence system. J Korean Med Sci. 2006 Apr;21(2):242-6. doi: 10.3346/jkms.2006.21.2.242.
- Background: PubMed 15923251Haussinger K, Becker H, Stanzel F, Kreuzer A, Schmidt B, Strausz J, Cavaliere S, Herth F, Kohlhaufl M, Muller KM, Huber RM, Pichlmeier U, Bolliger ChT. Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial. Thorax. 2005 Jun;60(6):496-503. doi: 10.1136/thx.2005.041475.
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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 LoCicero, MD principal investigator
Maimonides Medical Center
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 Lung Cancer, run by Antonios Likourezos at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 11 Dec 2023. 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 United States. 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 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?
Degree of correlation between three different bronchoscopic images (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548730, which also lists 7 linked publications.
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 11 Dec 2023.