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

March 8, 2024 updated by: Xuehan Gao, Peking Union Medical College Hospital

The Value of Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO) in Vitro: A Prospective Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Lung cancer (LC) is a leading cause of mortality worldwide. According to the International Agency for Research (IARC) on Cancer, LC was projected to contribute to 2.3 million new cancer cases and 1.8 million deaths worldwide in 2020. With widespread use of chest computed tomography (CT), LC is increasingly detected at an early stage, in which 63%-95% lesions present as ground glass opacity (GGO).

GGO refers to a non-specific radiological appearance, referring to a focal, hazy shadow with increased attenuation that does not obscure the contours of bronchi or blood vessels on CT. It can be benign lesions, preinvasive, or invasive adenocarcinoma. Surgery is the main treatment for suspected malignant GGOs. Whether excised targeted GGOs thoroughly affects patients' prognosis crucially, especially for patients with multiple GGOs. Generally, the most frequent intraoperative location approach of pulmonary nodules is palpation, which distinguished by the texture between normal lung tissue and nodules. However, different from solid nodules, the texture of GGO nodules is similar to lung parenchyma that increases the difficulty of palpation localization. Thus, detection of GGOs and in lung tissue poses a common challenge, particularly in the presence of pure GGO (tumor without an solid component) and small GGO nodules (≤1cm).

In the current clinical practice, even with preoperative localization (CT-guided percutaneous and intraoperative electromagnetic navigation bronchoscopy), it remains challenging to confirm complete resection of all small, pure GGOs. Therefore, there is an urgent need for a new method that can accurately evaluate nodules in excised lung tissue. Since Roberto used thoracoscopic ultrasound (TUS) to examine pulmonary nodules in 1999, subsequently, several studies have validated the safety and efficacy for using US in identifying pulmonary nodules intraoperatively. However, past research all focused on solid nodules or large nodules (maximum diameter more than 2cm) using 5-12MHz US transducer. Few studies have studied the detection rate of small GGO nodules.

Previous studies have found 12MHz of US probe could show pulmonary nodules better than 5MHz and 7.5MHz. Ultrahigh frequency ultrasound (UHFUS) refers to higher frequency (≥20MHz) ultrasound waves with higher resolution even less than 50μm. It is capable to display nodules less than 3mm distinctively in the extremely superficial tissue, which may satisfy intraoperative GGO imaging requirement. Therefore, the objects of this study are to assess the feasibility of localizing GGOs in excised lung tissue by UHFUS and further summarize its UHFUS features.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Department of Thoracic Surgery
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xuehan Gao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with targeted GGOs and will accept VATS or RATS resection

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
UHFUS
Pulmonary nodules were detected by UHFUS method.
Palpation
Pulmonary nodules were detected by palpation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate
Time Frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
Detection rate of UHFUS and palpation methods
From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection time
Time Frame: From enrollment to the end of surgery
Detection time of UHFUS and palpation methods
From enrollment to the end of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
UHFUS imaging features
Time Frame: From enrollment to the end of surgery
UHFUS imaging features of GGOs
From enrollment to the end of surgery
Tumor size
Time Frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
The agreement of tumor size measured by CT, UHFUS and pathology
From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Shanqing Li, Prof., Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UHFUSGGO01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, SAP, and ICF could be shared.

IPD Sharing Time Frame

6 months after the trial finnshed.

IPD Sharing Access Criteria

Contact investigators by email (GXH: gaoxh1299@163.com, GYJ: 610066214@qq.com).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe