Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO)

NCT05994898 | Recruiting

• 1 other identifier: UHFUSGGO01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility of UHFUS on detection of GGOs in excised lung tissue and investigate UHFUS features of GGO in vitro. Each GGO was detected by palpation, UHFUS and open biopsy in sequence. The comparison of detection rate and time consumption were analyzed respectively. The Bland-Altman analysis was used to estimate the agreement of tumor size measured by CT, UHFUS and pathology.

Conditions

Lung Nodules; Ultrasound; Detection Rate

Keywords

lung nodules; ground glass opacity; Ultrahigh frequency ultrasound

Outcome Measures

Primary Outcomes (1)

• Detection rate

  Detection rate of UHFUS and palpation methods

  From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)

Secondary Outcomes (1)

• Detection time

  From enrollment to the end of surgery

Other Outcomes (2)

• UHFUS imaging features

  From enrollment to the end of surgery

• Tumor size

  From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)

Study Arms (2)

UHFUS

Pulmonary nodules were detected by UHFUS method.

Palpation

Pulmonary nodules were detected by palpation method.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with targeted GGOs and will accept VATS or RATS resection

You may qualify if:

• Patients with targeted nodules identified as lesions required surgical removed such as main lesion and high-risk nodules;
• Patients who accept VATS or RATS resection.

You may not qualify if:

• Patients refused enrollment in the trial;
• Pulmonary nodules were labelled during the operation.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of thoracic surgery

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (9)

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  PMID: 27765176 BACKGROUND

• Yamamoto M, Takeo M, Meguro F, Ishikawa T. Sonographic evaluation for peripheral pulmonary nodules during video-assisted thoracoscopic surgery. Surg Endosc. 2003 May;17(5):825-7. doi: 10.1007/s00464-002-8900-0. Epub 2003 Jan 18.

  PMID: 12584601 BACKGROUND

• Sortini D, Feo CV, Carcoforo P, Carrella G, Pozza E, Liboni A, Sortini A. Thoracoscopic localization techniques for patients with solitary pulmonary nodule and history of malignancy. Ann Thorac Surg. 2005 Jan;79(1):258-62; discussion 262. doi: 10.1016/j.athoracsur.2004.06.012.

  PMID: 15620953 BACKGROUND

• Wada H, Anayama T, Hirohashi K, Nakajima T, Kato T, Waddell TK, Keshavjee S, Yoshino I, Yasufuku K. Thoracoscopic ultrasonography for localization of subcentimetre lung nodules. Eur J Cardiothorac Surg. 2016 Feb;49(2):690-7. doi: 10.1093/ejcts/ezv124. Epub 2015 Apr 7.

  PMID: 25855597 BACKGROUND

• Santambrogio R, Montorsi M, Bianchi P, Mantovani A, Ghelma F, Mezzetti M. Intraoperative ultrasound during thoracoscopic procedures for solitary pulmonary nodules. Ann Thorac Surg. 1999 Jul;68(1):218-22. doi: 10.1016/s0003-4975(99)00459-2.

  PMID: 10421144 BACKGROUND

• Matsunaga T, Suzuki K, Takamochi K, Oh S. What is the radiological definition of part-solid tumour in lung cancer?dagger. Eur J Cardiothorac Surg. 2017 Feb 1;51(2):242-247. doi: 10.1093/ejcts/ezw344.

  PMID: 28119328 BACKGROUND

• Hou YL, Wang YD, Guo HQ, Zhang Y, Guo Y, Han H. Ultrasound location of pulmonary nodules in video-assisted thoracoscopic surgery for precise sublobectomy. Thorac Cancer. 2020 May;11(5):1354-1360. doi: 10.1111/1759-7714.13384. Epub 2020 Mar 17.

  PMID: 32180358 BACKGROUND

• Zhang Y, Fu F, Chen H. Management of Ground-Glass Opacities in the Lung Cancer Spectrum. Ann Thorac Surg. 2020 Dec;110(6):1796-1804. doi: 10.1016/j.athoracsur.2020.04.094. Epub 2020 Jun 7.

  PMID: 32525031 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

Study Officials

• Shanqing Li, Prof.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehan Gao, MD

CONTACT

+86 18801341299; gaoxh1299@163.com

Yuanjing Gao, MD

CONTACT

+86 16619765781; 610066214@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: January 4, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after the trial finnshed.
• Access Criteria: Contact investigators by email (GXH: gaoxh1299@163.com, GYJ: 610066214@qq.com).

Locations

CN (1)