Clinical trial NCT05994898: Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO)
Official title: The Value of Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO) in Vitro: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Nodules
Ultrasound
Detection Rate
Keywords: lung nodules
ground glass opacity
Ultrahigh frequency ultrasound
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with targeted GGOs and will accept VATS or RATS resection

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate
timeFrame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
Secondary outcomes:
measure: Detection time
timeFrame: From enrollment to the end of surgery
Other outcomes:
measure: UHFUS imaging features
timeFrame: From enrollment to the end of surgery
measure: Tumor size
timeFrame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
Locations:
city: Beijing
country: China
facility: Department of thoracic surgery
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shanqing Li, Prof.
role: PRINCIPAL_INVESTIGATOR
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