Lung NodulesUHFUSGGONCT05994898
Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO)
An observational study of Lung Nodules and Ultrasound, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Nodules, Ultrasound, Detection Rate
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with targeted GGOs and will accept VATS or RATS resection
Who may be able to join
- 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.
Who cannot join
- Patients refused enrollment in the trial;
- Pulmonary nodules were labelled during the operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of thoracic surgery
Beijing, Beijing Municipality, 100730
Xuahan Gao, MD, +86 18801341299, gaoxh1299@163.com
Yuanjing Gao, MD, +86 16619765781, 610066214@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Nodules, Ultrasound, Detection Rate
- Keywords
- lung nodules, ground glass opacity, Ultrahigh frequency ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UHFUS | Pulmonary nodules were detected by UHFUS method. | |
| Palpation | Pulmonary nodules were detected by palpation method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate
Detection rate of UHFUS and palpation methods
Measured: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
Secondary outcomes (1)
Detection time
Detection time of UHFUS and palpation methods
Measured: From enrollment to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start4 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehan Gao, Peking Union Medical College Hospital
- Investigators
- Shanqing Li, Prof., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994898
- Sponsor's protocol ID
- UHFUSGGO01
- Acronym
- UHFUSGGO
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, SAP, and ICF could be shared.
Publications
Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.
PubMed 27765176Yamamoto 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.
PubMed 12584601Sortini 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.
PubMed 15620953Wada 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.
PubMed 25855597Santambrogio 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.
PubMed 10421144Matsunaga 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.
PubMed 28119328Hou 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.
PubMed 32180358Zhang 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.
PubMed 32525031Sung 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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO) in Vitro: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT05994898
- Acronym / sponsor ID
- UHFUSGGO / UHFUSGGO01
- Conditions
- Lung Nodules, Ultrasound, Detection Rate
- Keywords
- lung nodules, ground glass opacity, Ultrahigh frequency ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHFUS | – | –Pulmonary nodules were detected by UHFUS method. |
| Palpation | – | –Pulmonary nodules were detected by palpation method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with targeted GGOs and will accept VATS or RATS resection
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients refused enrollment in the trial;
- Pulmonary nodules were labelled during the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rate
Time frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
Detection rate of UHFUS and palpation methods
1 secondary outcome
Detection time
Time frame: From enrollment to the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 27765176Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.
- Background: PubMed 12584601Yamamoto 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.
- Background: PubMed 15620953Sortini 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.
- Background: PubMed 25855597Wada 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.
- Background: PubMed 10421144Santambrogio 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.
- Background: PubMed 28119328Matsunaga 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.
- Background: PubMed 32180358Hou 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.
- Background: PubMed 32525031Zhang 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.
- Background: PubMed 33538338Sung 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.
- Individual participant dataSharing planned: Yes. Study protocol, SAP, and ICF could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanqing Li, Prof. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodules and Ultrasound, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehan Gao, MD (+86 18801341299, gaoxh1299@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate (time frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994898, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.