The researchers hope to establish clear guidelines for physicians for determining the best way to follow patients with small lesions detected by chest CT scans that are most likely benign. In particular, they hope to establish the optimal frequency of follow-up with low-dose CT.
Nodules are detected incidentally on CT scans performed for various reasons, or sometimes as part of a CT lung cancer screening exam for high-risk patients, the UC Davis investigators said. Lung CT scans are used to evaluate any number of medical problems, including suspected pulmonary embolism, infection, or other lung diseases.
The trial will include 47,000 patients with small lung nodules identified on CT, an estimated 900 of whom will turn out to have lung cancer. The patients will be randomized into two groups: One group will be followed up with low-dose CT at six, 12, and 24 months, and the other group will be followed up with CT at only 12 and 24 months.
"When doctors receive reports about nodules in someone who had a scan for whatever reason, they don't know what to do with the information," said UC Davis researcher Diana Miglioretti, PhD, in a statement. "At the conclusion of this study, we want to say one of these two surveillance programs -- either the less intense or the more intense -- is appropriate. We want to make sure that whichever approach is chosen, it will give us the optimal number of early-stage lung cancers, while reducing harms such as excess radiation exposure and benign biopsies."
Miglioretti and Dr. Karen Kelly are co-principal investigators on the grant, which was awarded by the Patient-Centered Outcomes Research Institute (PCORI) as part of a $64 million program to answer critical questions about care for cancer, back pain, and stroke.
The two investigators will run the trial, along with Dr. Rebecca Smith-Bindman from the University of California, San Francisco and pulmonologist Dr. Michael Gould of Kaiser Permanente Southern California.
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