Status:
UNKNOWN
nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Mauna Kea Technologies
Johnson & Johnson
Conditions:
Diagnosis of Peripheral Lung Nodules
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04441749
Start Date
June 29 2020
End Date
December 1 2023
Last Update
February 8 2023
Active Locations (2)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
2
Amsterdam University Medical Center
Amsterdam, AZ, Netherlands, 1105