Lung CancerOCTNCT01039311
Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
An observational study of Lung Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies. 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?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2012
- 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: Patients ages 18-99 with the presence of of an endobronchial mass.
Who may be able to join
- Subjects 18-99 years of age
- Presence of an endobronchial mass
- Need for flexible bronchoscopy, with endobronchial biopsies
Who cannot join
- PCO2 > 47 mm Hg, and/or long term Oxygen therapy
- Unwillingness to undergo fiberoptic bronchoscopy
- Coagulopathy, defined as a platelets count < 100.000/mm3, or an INR> 1.4, or known clinical bleeding disorder
- Therapy with anticoagulant, including Coumadin and Clopidogrel
- Renal dysfunction, defined as a Creatinine > 2 mg/dl
- Life-threatening arrhythmias, or history of myocardial infarction within 6 months
Show all 13Show fewer
- Cerebrovascular Accident within the preceding 6 months
- Facial abnormality preventing safe introduction of the bronchoscope
- Uncontrolled hypertension
- Active liver disease
- Pregnancy or Breastfeeding
- Prisoners
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.
Read the detailed description
OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.
- Conditions
- Lung Cancer
- Being tested
- Optical Coherence Tomography
- Keywords
- Lung, cancer, bronchoscopy, optical, coherence, tomography
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
Also called Imalux Niris
Obtain OCT images.
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography | Examine OCT images and compare them to conventional biopsies in same subject. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT image sensitivity and specificity in diagnosis of lung cancer.
Measured: Every 3 months
Secondary outcomes (1)
Feasibility and safety of obtaining OCT images during flexible bronchoscopy.
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Unable to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Jean Keddissi, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039311
- Sponsor's protocol ID
- 14370
- Acronym
- OCT
- Status last verified
- Jan 2013
- First submitted
- 11 Dec 2009
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michel RG, Kinasewitz GT, Fung KM, Keddissi JI. Optical coherence tomography as an adjunct to flexible bronchoscopy in the diagnosis of lung cancer: a pilot study. Chest. 2010 Oct;138(4):984-8. doi: 10.1378/chest.10-0753. Epub 2010 May 14.
PubMed 20472863
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT01039311
- Acronym / sponsor ID
- OCT / 14370
- Conditions
- Lung Cancer
- Keywords
- Lung, cancer, bronchoscopy, optical, coherence, tomography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to enroll subjects
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Dec 2009 (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.
Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.
Detailed description
OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography | – | Device: Optical Coherence TomographyExamine OCT images and compare them to conventional biopsies in same subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ages 18-99 with the presence of of an endobronchial mass.
Key inclusion criteria (3 listed)
- Subjects 18-99 years of age
- Presence of an endobronchial mass
- Need for flexible bronchoscopy, with endobronchial biopsies
Key exclusion criteria (13 listed)
- PCO2 > 47 mm Hg, and/or long term Oxygen therapy
- Unwillingness to undergo fiberoptic bronchoscopy
- Coagulopathy, defined as a platelets count < 100.000/mm3, or an INR> 1.4, or known clinical bleeding disorder
- Therapy with anticoagulant, including Coumadin and Clopidogrel
- Renal dysfunction, defined as a Creatinine > 2 mg/dl
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 |
|---|---|---|
| Optical Coherence TomographyAlso: Imalux NirisObtain OCT images. | Device | Optical Coherence Tomography |
Primary outcome
OCT image sensitivity and specificity in diagnosis of lung cancer.
Time frame: Every 3 months
1 secondary outcome
Feasibility and safety of obtaining OCT images during flexible bronchoscopy.
Time frame: Every 3 months
Results and safety
The study was stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
- Derived from this study: PubMed 20472863Michel RG, Kinasewitz GT, Fung KM, Keddissi JI. Optical coherence tomography as an adjunct to flexible bronchoscopy in the diagnosis of lung cancer: a pilot study. Chest. 2010 Oct;138(4):984-8. doi: 10.1378/chest.10-0753. Epub 2010 May 14.
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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.
Jean Keddissi, MD principal investigator
University of Oklahoma
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 University of Oklahoma 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Feb 2013. 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 stopped early (reason given: Unable to enroll subjects). Results are not available in the source record.
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?
OCT image sensitivity and specificity in diagnosis of lung cancer. (time frame: Every 3 months). 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 NCT01039311, which also lists 1 linked publication.
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 1 Feb 2013.