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Did you know how lung imaging reveals hidden signs of cancer?
In modern medicine, the application of imaging biomarkers has received increasing attention. These biomarkers not only provide visualization of pathological characteristics, but also help doctors make key judgments in early detection of cancer, especially in the diagnosis and treatment of lung cancer.
Imaging biomarkers are imaging features that are relevant to patient diagnosis.
Lung imaging, such as X-rays, CT or MRI, can detect simple lung lesions that can be potential indicators of cancer. These lesions themselves serve as biomarkers, and subtle changes in them can also serve as markers for assessing cancer risk. For example, the size of the lesion, edge characteristics such as spiculation, degree of calcification, cavitation, location within the lung, growth rate, and metabolic rate are all imaging biomarkers used to evaluate pulmonary nodules. The information provided by each image is a probability that can be combined with the patient's history, physical examination, laboratory tests and pathology data to arrive at a potential diagnosis.
For example, the lack of any growth features often points to benign lesions, while irregular edges raise the possibility of cancer.
Imaging biomarkers can be measured through a variety of techniques, including CT, PET, SPECT, ultrasonography, electroencephalography, magnetic resonance electrophysiology, and MRI. This wide range of technological applications demonstrates the importance and complexity of imaging biomarkers in medical imaging.
Historical background
Imaging biomarkers are almost as old as X-rays themselves. Initially, imaging features called "Roentgen signs" were discovered by Wilhelm Röntgen to describe pathological changes. With the development of medical imaging technology, the number and complexity of imaging biomarkers have also increased, and now extend further to the field of chemical imaging.
Development of quantitative imaging biomarkers
The concept of quantitative imaging biomarkers (QIB) is based on the measurement of objective characteristics and is based on indicators on a ratio or interval scale to show normal biological processes, pathological processes, or responses to therapeutic interventions. Compared with qualitative imaging biomarkers, QIB has more advantages in application in patient follow-up or clinical trials. An early example of a QIB is the RECIST criterion, which is used to assess changes in tumor size in cancer patients to assess treatment effectiveness.
Application in clinical trials
Clinical trials are considered one of the most valuable sources of data in evidence-based medicine. In order for a medical product to be approved for use in the United States, it must be rigorously tested in clinical trials and demonstrate adequate efficacy. The introduction of biomarkers in this process helps to identify the physiological and pathological changes of the disease before they are clinically detected, thereby serving as a surrogate outcome indicator and significantly reducing the time and resources required for clinical trials. .
Enabling researchers to assess markers rather than patients allows participants to serve as their own controls and makes blind testing easier in many cases.
FDA approval process
The U.S. Congress and the Food and Drug Administration (FDA) have recognized the value of imaging biomarkers. The FDA Modernization Act of 1997 improved the regulatory process for medical products and authorized expedited approval of drugs for serious diseases as long as the drugs showed efficacy on alternative parameters of clinical benefit.
Qualification and verification of biomarkers
The certification process required for the clinical significance of a specific biomarker can be cumbersome. This process is divided into two steps: qualification and verification. Qualification needs to be completed through a formal process. Biomarkers must go through the corresponding application process and be evaluated by a team of experts to determine the validity and rationality of their use.
Quality standards
There are three main quality standards for the use of enhanced biomarkers in clinical trials: the presence of imaging biomarkers must be closely related to the target disease or condition; their detection and quantification must be accurate, reproducible, and temporally feasible; and imaging Changes in biomarkers over time must be closely related to the success or failure of treatment efficacy.
Organizational cooperation
Because compiling a database of validated biomarkers requires significant resources, FDA encourages public-private collaborations to establish alliances to promote data sharing to facilitate biomarker qualification and validation. Various organizations, such as the Biomarker Alliance and the Predictive Safety Testing Alliance, are actively working to promote the development and application of biomarkers.
Against this background, imaging biomarkers are undoubtedly shaping the future of diagnosis and treatment of lung cancer. But how much undiscovered potential is hidden behind these advances?
