Using Optical Coherence Tomography to Guide Biopsies of Lung Lesions
Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions
This study is testing if using a special imaging technique called Optical Coherence Tomography with ultrasound can help doctors take better biopsies of hard-to-reach lung lesions in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06419114 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Optical Coherence Tomography (OCT) combined with Radial Endobronchial Ultrasound (R-EBUS) to guide transbronchial biopsies in patients with peripheral pulmonary lesions (PPLs). Conducted at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital, the study collects data from patients who meet specific eligibility criteria, including recent CT scans indicating PPLs that could not be detected through standard bronchoscopy. The aim is to improve diagnostic accuracy and patient outcomes in lung neoplasm cases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with peripheral pulmonary lesions identified by CT scans who have not been able to undergo successful biopsy through routine bronchoscopy.
Not a fit: Patients with contraindications to bronchoscopy or those who refuse the procedure for personal or physical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of lung biopsies, leading to better diagnosis and treatment options for patients with lung neoplasms.
How similar studies have performed: While this approach is innovative, similar studies utilizing advanced imaging techniques for biopsy guidance have shown promise in improving diagnostic outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria of this study were as followed: (1)Clinical diagnosis of PPL's by chest computed tomography (CT) within 2 weeks, (2)voluntary participation and written informed consent signed, (3) age ≥ 18 years old, (4) the platelets count and PT, APTT tests were normal, (5) normal ECG and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant.
Where this trial is running
Chengdu, Sichuan
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Guanghong Zhou, master
- Email: zhough0526@163.com
- Phone: 8618302880040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.