This study is researching an experimental drug called odronextamab, referred to as study
drug. The study is focused on participants with previously untreated follicular lymphoma (a
type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized -
controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug
is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab
and chemotherapy (the current standard of care for NHL). Standard of care means the usual
medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in your blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less
effective or could lead to side effects)
- The impact from the study drug on your quality of life and ability to complete routine
daily activities.
Study finds navigational bronchoscopy as effective and safer alternative to transthoracic biopsy for lung nodules
Navigational bronchoscopy is as effective as the traditionally used transthoracic needle biopsy for diagnosing lung nodules, but with significantly fewer complications, per a new study published May 18 in the New England Journal of Medicine. This development may shift medical practice and reduce hospitalizations for patients undergoing lung nodule biopsies, said researchers.
Each year, millions of lung nodules are detected during routine X-rays or CT scans. While most nodules are benign, some are cancerous and when found at this stage they are the earliest and most curable stage of lung cancer.
Accurate biopsy of lung nodules is often required to tell benign nodules from malignant ones. To date, the most commonly used method, CT-guided transthoracic needle biopsy, carries a high complication rate — including pneumothorax, or partial lung collapse, affecting about 25% of patients. Treatment of the partially collapsed lung often requires a chest tube during a multiple day inpatient stay.
This study is the first to directly compare these biopsy techniques and the results are compelling, said first author Robert Lentz, MD, associate professor of Medicine and Thoracic Surgery in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center. The study, conducted across seven centers in the United States, compared the two techniques in a multicenter, randomized trial involving 234 patients with lung nodules between 10-30 mm.
Navigational bronchoscopy uses a sophisticated targeting system and 3D imaging to guide biopsy tools through small peripheral airways directly to a lung nodule.
The comparison revealed a diagnostic accuracy of 79% using navigational technology, closely matching the 74% accuracy of transthoracic biopsy. More importantly, the risk of pneumothorax was significantly lower, occurring in only 3% of bronchoscopy patients compared to 35% in those undergoing transthoracic biopsy. Severe cases requiring hospital admission or chest tube insertion were less than 1% with bronchoscopy, as opposed to 14% with the traditional method.
“With approximately 300,000 lung nodule biopsies performed annually in the U.S., shifting to navigational bronchoscopy could greatly reduce complications and hospital stays. This study confirms its diagnostic efficacy and superior safety profile, making it the preferred choice for lung nodule diagnosis,” said senior author Fabien Maldonado, MD, MSc, professor of Medicine and Thoracic Surgery and director of Interventional Pulmonology.
The research team plans to continue exploring optimal biopsy techniques, comparing different navigational and robotic bronchoscopy systems, and studying novel biopsy tools, said Maldonado, Pierre Massion Director in Lung Cancer Research.
They are also involved in research on bronchoscopic ablation of lung cancer, advancing the field of interventional pulmonology.
“As a relatively new medical subspecialty, we are quite proud and excited to have matured our research infrastructure to the point of being able to produce high quality multicenter trials like this, and hope that publication of this trial will serve as an introduction of sorts for interventional pulmonology to the larger general medical audience,” said Lentz.
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