Diagnosis of Peripheral Lung NodulesNCT04441749
nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
An observational study of Diagnosis of Peripheral Lung Nodules, run by Fox Chase Cancer Center at 2 sites in 2 countries.
Trial summary
Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis of Peripheral Lung Nodules
- What is being tested?
- Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Jun 2020to Dec 2023
- 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 will be enrolled from outpatient pulmonary clinic and from direct referrals from the inpatient pulmonary service and thoracic tumor board. Patients who scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion at Fox Chase Fox Center will be contacted to participate in the study.
Who may be able to join
- Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
- Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm
- Age > 18 years.
- Patients must have normal organ and marrow functions as defined below:
- Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Total bilirubin within normal institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) < 2 times institutional normal limits Creatinine OR Creatinine Clearance within normal institutional limits OR > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- WOCBP must agree not to get pregnant until after the day of the procedure
Who cannot join
- Patients with uncorrectable coagulopathy will be excluded.
- Known allergy to fluorescein or other contrast media
- Patients with hemodynamic instability will be excluded
- Patients with refractory hypoxemia will be excluded
- Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
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- Patient requires chemotherapy
- Pregnant or breast feeding. Refer to section 4.5 for further detail.
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- Pregnancy:
- Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will be excluded from the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: TH-168: Needle Based Confocal Laser Endomicroscopy For The Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in conjunction with robotic navigational bronchoscopy.
- Conditions
- Diagnosis of Peripheral Lung Nodules
- Being tested
- Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)Device
Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed
| Study group | Role | What they receive |
|---|---|---|
| nCLE Analysis | Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis Receives: Device: Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to obtain good quality nCLE images of lung nodules
Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start29 Jun 2020
- Primary completion20 Sep 2021
- Study completionDec 2023 (estimated)
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 Diagnosis of Peripheral Lung NodulesStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mauna Kea Technologies, Johnson & Johnson
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441749
- Sponsor's protocol ID
- 20-1006
- Other IDs
- TH-168
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Manley CJ, Kramer T, Kumar R, Gong Y, Ehya H, Ross E, Bonta PI, Annema JT. Robotic bronchoscopic needle-based confocal laser endomicroscopy to diagnose peripheral lung nodules. Respirology. 2023 May;28(5):475-483. doi: 10.1111/resp.14438. Epub 2022 Dec 19.
PubMed 36535801
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TH-168: Needle Based Confocal Laser Endomicroscopy For The Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
- ClinicalTrials.gov ID
- NCT04441749
- Acronym / sponsor ID
- 20-1006
- Conditions
- Diagnosis of Peripheral Lung Nodules
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Mauna Kea Technologies, Johnson & Johnson
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jun 2020 (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.
Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in conjunction with robotic navigational bronchoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nCLE Analysis | – | Device: Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from outpatient pulmonary clinic and from direct referrals from the inpatient pulmonary service and thoracic tumor board. Patients who scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion at Fox Chase Fox Center will be contacted to participate in the study.
Key inclusion criteria (7 listed)
- Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
- Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm
- Age > 18 years.
- Patients must have normal organ and marrow functions as defined below:
- Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Total bilirubin within normal institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) < 2 times institutional normal limits Creatinine OR Creatinine Clearance within normal institutional limits OR > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Key exclusion criteria (11 listed)
- Patients with uncorrectable coagulopathy will be excluded.
- Known allergy to fluorescein or other contrast media
- Patients with hemodynamic instability will be excluded
- Patients with refractory hypoxemia will be excluded
- Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure
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 |
|---|---|---|
| Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed | Device | nCLE Analysis |
Primary outcome
Ability to obtain good quality nCLE images of lung nodules
Time frame: 1 year
Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 36535801Manley CJ, Kramer T, Kumar R, Gong Y, Ehya H, Ross E, Bonta PI, Annema JT. Robotic bronchoscopic needle-based confocal laser endomicroscopy to diagnose peripheral lung nodules. Respirology. 2023 May;28(5):475-483. doi: 10.1111/resp.14438. Epub 2022 Dec 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis of Peripheral Lung Nodules, run by Fox Chase Cancer Center at 2 sites in 2 countries.
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 7 inclusion and 11 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Netherlands. 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?
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?
Ability to obtain good quality nCLE images of lung nodules (time frame: 1 year). 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 NCT04441749, 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 8 Feb 2023.