Surveillance for Multifocal GGNs

Launched by FUDAN UNIVERSITY · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a method called active surveillance for patients with multifocal ground-glass opacities in the lungs. Ground-glass opacities are areas on a lung scan that may indicate the presence of early-stage lung cancer. Instead of immediately undergoing surgery, the trial aims to see if closely monitoring these patients can lead to similar or better survival outcomes. The study is currently recruiting participants aged between 18 and 75 who have specific conditions seen on their CT scans, such as stable ground-glass opacities that have not changed in size over the past three months.

To participate, individuals must have at least three stable ground-glass opacities, with one being slightly larger than the others. They should not have had any previous cancer treatment or lung surgery and must be in good overall health. Those who join the study can expect regular check-ins and scans to monitor their condition without immediate surgery. This approach allows researchers to gather important information about the safety and effectiveness of active surveillance for this type of lung finding.

Gender

ALL

Eligibility criteria

• • Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.
• 1. Demonstrates the following on thin-section computed tomography (TSCT) scan:
• • 1. Presence of three or more GGNs (bilateral lesions are permitted).
• • 2. All lesions have remained stable without regression or enlargement for at least 3 months.
• • 3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter \>=0.6cm and \<=2cm.
• • 4. CTR \<=0.25 in all lesions.
• • 5. No lymph node with a diameter \>1cm in the mediastinal view.
• • 6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
• • 2. Aged 18-75 years.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 4. Has not previously undergo any anti-tumor drug or radiation therapy.
• • 5. Written informed consent.
• • Exclusion criteria Patients will be excluded if they meet any of the following criteria.
• • 1. History of any prior malignancies within the past 5 years.
• • 2. History of lung surgery.
• • 3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
• • 4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.