Study Results
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View full resultsBasic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2021-03-05
2023-04-12
Brief Summary
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Detailed Description
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The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.
The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.
This research study involves a screening period, a procedure and follow up visits.
The names of the study interventions involved in this study are:
* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone
Participants will receive the study procedure and will be followed for up to 6 months.
It is expected that about 136 people will take part in this research study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Navigation Bronchoscopy ALONE
This research study involves a screening period, a procedure and follow up visits
* Procedure Visit Navigation Bronchoscopy Alone
* Follow-Up Visits at Week 1, 4 and 12
Navigation Bronchoscopy
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
CBCT-GUIDED Navigation Bronchoscopy
This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules
-Follow-Up Visits at Week 1, 4 and 12
Navigation Bronchoscopy
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
Cone beam computed tomography (CBCT)
Per Protocol
Interventions
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Navigation Bronchoscopy
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
Cone beam computed tomography (CBCT)
Per Protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist.
* Participants with higher risk lesions (pCA \> 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery.
* Participants are willing and able to provide informed consent.
Exclusion Criteria
* There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA).
* Lacked fitness according to physician judgement to undergo bronchoscopy.
* Contraindication for temporary interruption of the use of anticoagulant therapy.
* Uncontrolled or irreversible coagulopathy.
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent (\< 4 weeks) and/or uncontrolled cardiac disease.
* Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe).
* ASA classification ≥ 4.
* COVID-19 positive participant at the time of procedure.
18 Years
ALL
Yes
Sponsors
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Philips Healthcare
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Adnan Majid, MD
Principal Investigator
Principal Investigators
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Adnan Majid, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Countries
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References
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Choi JW, Park CM, Goo JM, Park YK, Sung W, Lee HJ, Lee SM, Ko JY, Shim MS. C-arm cone-beam CT-guided percutaneous transthoracic needle biopsy of small (</= 20 mm) lung nodules: diagnostic accuracy and complications in 161 patients. AJR Am J Roentgenol. 2012 Sep;199(3):W322-30. doi: 10.2214/AJR.11.7576.
Hur J, Lee HJ, Nam JE, Kim YJ, Kim TH, Choe KO, Choi BW. Diagnostic accuracy of CT fluoroscopy-guided needle aspiration biopsy of ground-glass opacity pulmonary lesions. AJR Am J Roentgenol. 2009 Mar;192(3):629-34. doi: 10.2214/AJR.08.1366.
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Wiener RS, Schwartz LM, Woloshin S, Welch HG. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. 2011 Aug 2;155(3):137-44. doi: 10.7326/0003-4819-155-3-201108020-00003.
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Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.
Ali EAA, Takizawa H, Kawakita N, Sawada T, Tsuboi M, Toba H, Takashima M, Matsumoto D, Yoshida M, Kawakami Y, Kondo K, Khairy El-Badrawy M, Tangoku A. Transbronchial Biopsy Using an Ultrathin Bronchoscope Guided by Cone-Beam Computed Tomography and Virtual Bronchoscopic Navigation in the Diagnosis of Pulmonary Nodules. Respiration. 2019;98(4):321-328. doi: 10.1159/000500228. Epub 2019 May 23.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20-580
Identifier Type: -
Identifier Source: org_study_id
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