ROSE Technique for Non-Small Cell Lung Cancer Biopsies

(ROSE/NoROSE Trial)

This trial examines two methods of performing a bronchoscopic biopsy for individuals with non-small cell lung cancer (NSCLC). The study compares the effectiveness of having a cytotechnologist (a specialist who examines cells under a microscope) on-site during the procedure in obtaining useful samples. Participants are divided into groups, with some having this specialist present and others not, and samples are prepared in different ways. Individuals with known or suspected NSCLC who are referred for tissue sampling at Johns Hopkins sites may be suitable candidates. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance biopsy procedures.

The trial does not specify if you need to stop taking your current medications, but if you are using antiplatelet or anticoagulant drugs (medications that prevent blood clots), you may not be eligible to participate.

Research has shown that the ROSE technique is safe and helpful for lung cancer biopsies. Studies have found that it helps doctors accurately identify cancer during the procedure, making the diagnosis of lung cancer faster and more reliable.

No serious safety concerns have been reported with ROSE. Its main purpose is to improve biopsy accuracy, not to alter its safety. Having a cytotechnologist (a specialist who examines cells) present during the procedure does not add any risk.

Researchers are excited about the ROSE technique for non-small cell lung cancer biopsies because it aims to improve the accuracy and efficiency of bronchoscopic biopsies. Unlike traditional methods, the ROSE technique involves the presence of a trained cytotechnologist who provides immediate feedback to the bronchoscopist, which can enhance the quality of the sample collected. This real-time analysis could potentially reduce the need for repeat procedures and ensure a more accurate diagnosis. Additionally, the trial explores different sample preparations—tissue clot versus liquid—which may offer insights into optimizing biopsy results.

This trial will compare the ROSE technique with the NO-ROSE approach in bronchoscopic biopsies for non-small cell lung cancer. Research has shown that the ROSE technique, which involves a trained cytotechnologist providing on-site cytopathology feedback, accurately determines if lung tissue is cancerous during a biopsy. It distinguishes between non-cancerous and cancerous growths and effectively identifies different types of lung cancer. Studies have found that ROSE is both sensitive and specific, meaning it detects cancer when present and avoids false alarms. Using ROSE in biopsies enhances accuracy and can reduce the need for repeat procedures, making it a promising method for improving lung cancer diagnosis during bronchoscopies. Participants in this trial will be assigned to either the ROSE or NO-ROSE arms to evaluate these outcomes.¹³⁵⁶⁷