- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441749
nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
TH-168: Needle Based Confocal Laser Endomicroscopy For The Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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AZ
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Amsterdam, AZ, Netherlands, 1105
- Amsterdam University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to obtain good quality nCLE images of lung nodules
Time Frame: 1 year
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Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1006
- TH-168 (OTHER: Fox Chase cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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