Bronchoskopia nawigacyjna pod kontrolą CBCT w przypadku guzków płucnych
Tomografia komputerowa wiązki stożkowej — bronchoskopia z nawigacją w celu wykrycia obwodowych guzków płucnych: badanie z randomizacją
The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Beth Israel Deaconness Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Participants ≥18 years old.
- 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:
- The participant is pregnant as confirmed by urine or serum pregnancy testing.
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Navigation Bronchoscopy ALONE
This research study involves a screening period, a procedure and follow up visits
|
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
Inne nazwy:
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Eksperymentalny: 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 procedure will be performed per product instructions and the institution's standard practice.
Inne nazwy:
Per Protocol |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Diagnostic Yield
Ramy czasowe: 6 months
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The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value <0.05 will be considered as statistically significant. |
6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Incidence of Procedure-related Complications
Ramy czasowe: 6 months
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To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy. |
6 months
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Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.
Ramy czasowe: 6 Months
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To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy. |
6 Months
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Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.
Ramy czasowe: 6 Months
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To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy. |
6 Months
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Adnan Majid, MD, Beth Israel Deaconess Medical Center
Publikacje i pomocne linki
Publikacje ogólne
- Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
- Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.
- 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.
- Ohno Y, Hatabu H, Takenaka D, Higashino T, Watanabe H, Ohbayashi C, Sugimura K. CT-guided transthoracic needle aspiration biopsy of small (< or = 20 mm) solitary pulmonary nodules. AJR Am J Roentgenol. 2003 Jun;180(6):1665-9. doi: 10.2214/ajr.180.6.1801665.
- Laspas F, Roussakis A, Efthimiadou R, Papaioannou D, Papadopoulos S, Andreou J. Percutaneous CT-guided fine-needle aspiration of pulmonary lesions: Results and complications in 409 patients. J Med Imaging Radiat Oncol. 2008 Oct;52(5):458-62. doi: 10.1111/j.1440-1673.2008.01990.x.
- DiBardino DM, Yarmus LB, Semaan RW. Transthoracic needle biopsy of the lung. J Thorac Dis. 2015 Dec;7(Suppl 4):S304-16. doi: 10.3978/j.issn.2072-1439.2015.12.16.
- 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.
- Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.
- Ernst A, Simoff M, Ost D, Michaud G, Chandra D, Herth FJ. A multicenter, prospective, advanced diagnostic bronchoscopy outcomes registry. Chest. 2010 Jul;138(1):165-70. doi: 10.1378/chest.09-2457. Epub 2010 Apr 2.
- Asano F, Aoe M, Ohsaki Y, Okada Y, Sasada S, Sato S, Suzuki E, Senba H, Fujino S, Ohmori K. Deaths and complications associated with respiratory endoscopy: a survey by the Japan Society for Respiratory Endoscopy in 2010. Respirology. 2012 Apr;17(3):478-85. doi: 10.1111/j.1440-1843.2011.02123.x.
- 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.
- Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12.
- Pritchett MA, Schampaert S, de Groot JAH, Schirmer CC, van der Bom I. Cone-Beam CT With Augmented Fluoroscopy Combined With Electromagnetic Navigation Bronchoscopy for Biopsy of Pulmonary Nodules. J Bronchology Interv Pulmonol. 2018 Oct;25(4):274-282. doi: 10.1097/LBR.0000000000000536.
- Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.
- Bowling MR, Brown C, Anciano CJ. Feasibility and Safety of the Transbronchial Access Tool for Peripheral Pulmonary Nodule and Mass. Ann Thorac Surg. 2017 Aug;104(2):443-449. doi: 10.1016/j.athoracsur.2017.02.035. Epub 2017 May 17.
- Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21.
- Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.
- Popovich J Jr, Kvale PA, Eichenhorn MS, Radke JR, Ohorodnik JM, Fine G. Diagnostic accuracy of multiple biopsies from flexible fiberoptic bronchoscopy. A comparison of central versus peripheral carcinoma. Am Rev Respir Dis. 1982 May;125(5):521-3. doi: 10.1164/arrd.1982.125.5.521.
- Shure D, Astarita RW. Bronchogenic carcinoma presenting as an endobronchial mass. Chest. 1983 Jun;83(6):865-7. doi: 10.1378/chest.83.6.865.
- Chopra SK, Genovesi MG, Simmons DH, Gothe B. Fiberoptic bronchoscopy in the diagnosis of lung cancer comparison of pre-and post-bronchoscopy sputa, washings, bruchings and biopsies. Acta Cytol. 1977 Jul-Aug;21(4):524-7.
- Hohenforst-Schmidt W, Zarogoulidis P, Vogl T, Turner JF, Browning R, Linsmeier B, Huang H, Li Q, Darwiche K, Freitag L, Simoff M, Kioumis I, Zarogoulidis K, Brachmann J. Cone Beam Computertomography (CBCT) in Interventional Chest Medicine - High Feasibility for Endobronchial Realtime Navigation. J Cancer. 2014 Mar 9;5(3):231-41. doi: 10.7150/jca.8834. eCollection 2014.
- Wallis S. Z-squared: The Origin and Application of χ 2. J Quant Linguist [Internet]. 2013 Nov 12 [cited 2020 Nov 4];20(4):350-78. Available from: http://www.tandfonline.com/doi/abs/10.1080/09296174.2013.830554
- National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 20-580
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Ramy czasowe udostępniania IPD
Data can be shared no earlier than 1 year following the date of publication
Kryteria dostępu do udostępniania IPD
Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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