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Trial record 1 of 1 for:    04441749
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nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

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ClinicalTrials.gov Identifier: NCT04441749
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborators:
Mauna Kea Technologies
Johnson & Johnson
Information provided by (Responsible Party):
Fox Chase Cancer Center

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 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.

Condition or disease Intervention/treatment
Diagnosis of Peripheral Lung Nodules Device: Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TH-168: Needle Based Confocal Laser Endomicroscopy For The Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Group/Cohort Intervention/treatment
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
Device: 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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Tissue lung nodule) acquisition by transbronchial needle aspiration/ biopsy (standard of care)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441749


Contacts
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Contact: Christopher J Manley, MD 215-728-5703 christopher.manley@fccc.edu

Locations
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United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Christopher J Mmanley, MD    215-728-5703    christopher.manley@fccc.edu   
Sub-Investigator: Hormoz Ehya, MD         
Sub-Investigator: Yulan Gong, MD         
Sub-Investigator: Rohit Kumar, MD         
Principal Investigator: Christopher J Manley, MD         
Netherlands
Amsterdam University Medical Center Not yet recruiting
Amsterdam, AZ, Netherlands, 1105
Contact: Jouke T Annema, MD, PhD    +31 20 566 3852    j.t.annema@amsterdamumc.nl   
Sub-Investigator: Peter I Bonta, MD, PhD         
Sub-Investigator: Lizzy Wijmans, MD         
Sub-Investigator: Tess Kremer, MD         
Sub-Investigator: Martijn Bruin, MD         
Sponsors and Collaborators
Fox Chase Cancer Center
Mauna Kea Technologies
Johnson & Johnson
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT04441749    
Other Study ID Numbers: 20-1006
TH-168 ( Other Identifier: Fox Chase cancer Center )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No