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Standards of Care
Current standards of care

The diagnostic tools most commonly used to detect and localize lung cancer are sputum cytology, bronchoscopy, x-ray, and computed tomography (CT). There is no single standard of care for early lung cancer screening, but CT scans are gaining momentum as the detection method of choice.

With advances in resolution, CT can now detect nodules in the lung as small as 1mm. This makes CT a very sensitive tool for the detection of lung cancer, but as the resolution of CT scanners has increased so has the fraction of patients found to have suspicious nodules. This suggests that there is a specificity problem with CT, leading to a high rate of false positive results (low specificity). Typically, 95% of nodules found by screening CT are eventually determined to be benign.(3)

LungSign™ — a compliment to CT

LungSign™ is a complimentary approach to patient diagnostic management. There are two distinct ways in which LungSign supports CT: (1) by providing a measure of malignancy that can expidite diagnosis and reduce the need for repeat CT scanning; and (2) as a test before CT scanning.

According to recent publications, most high-risk individuals who undergo CT will be found to have pulmonary nodules, but 92-96%(3) of those nodules will prove to be benign. On a diagnostic track that can require two years to conclude, patients with positive scans accrue additional costs, radiation exposure and increased anxiety. A negative LungSign™ test result can reassure patients during the period where nodule growth is being assessed. On the other hand, a positive LungSign™ test result can provide biological evidence of malignancy in support of a nodule-positive CT scan result, and contribute to a more rapid evaluation.

LungSign™ — before CT

LungSign™'s second role is as a pre-CT test. This provides an opportunity to identify a very high risk group for CT and diagnostic follow-up to avoid cost and radiation exposure, particularly among patient groups with whom radiation should be limited — lung cancer survivors; patients exposed to other radiology-based screening methods (e.g., mammography). LungSign™ also helps to indicate the presence of bronchial cancers, which would otherwise be missed during CT alone.

Lung Cancer detection methodologies: further discussion

1. Sputum cytology: one of the oldest approaches to detecting lung cancer, sputum cytology relies on finding cancerous cells in the fluids brought up from the lungs. Sputum cytology is not widely used for early detection due to its low sensitivity, since malignant cells are usually not found in the sputum specimens of patients with early lung cancer.

2. Bronchoscopy: although bronchoscopy does allow direct observation of the large airways, it has limited ability to visualize the lung's periphery, where approximately 40% of all lung cancers occur. Furthermore, the invasiveness and expense of bronchoscopy limit its use as a detection tool.

3. X-ray: X-ray technology has been a much-used lung cancer detection method for many years. However, x-rays do not identify tumors smaller than 2cm, limiting their usefullness for early detection. X-rays also generate a high number of false positive readings, since other pulmonary conditions, such as infections, TB and sarcoidosis, produce radiographs with similar appearance to lung cancer.

4. CT Scans: Computed Tomography (CT) is emerging as a powerful tool for the detection of lung cancer. Unfortunately, CT scans alone can often not distinguish between benign and malignant nodules.

In the ongoing US National Lung Screening Trial (NLIST), which utilizes CT as a method of early lung cancer screening, most volunteers have been fount to have suspicious nodules that require follow up. Follow up typically consists of a higher-dose, diagnostic CT scan, repeat scanning after a period of three to six months, fine needle aspiration or biopsy. It can take up to two years, and as many as nine CT scans, to establish a diagnosis.

In addition to its high rate of false positives, some physicians worry about the effect of CT radiation exposure. Low dose CT scans subject patients to a radiation dose equivalent to 50-100 chest x-rays. (4) While the risk to an individual is statistically small, the effect on the general population could become significant as CT scans grow in popularity.

Given the aggressive nature of lung cancer, concerns about radiation-induced malignancy are often secondary to a need for diagnosis. In consequence, CT is fast becoming the dominant approach for lung cancer detection.

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  Perceptronix is a cancer diagnostic service company focused on detecting cancer at early stages to improve patient outcomes.