Guidance published today (29 August) by NICE supports the use of contrast-enhanced ultrasound with SonoVue (Bracco UK) to diagnose liver cancer. The guidance recommends the use of SonoVue in adults to investigate damage (lesions) to the liver that is detected incidentally, but not characterised, on an unenhanced ultrasound scan. The guidance also recommends its use in adults to investigate potential liver cancer that has spread from other cancers in the body, and to investigate liver damage in adults with cirrhosis where unenhanced ultrasound (US) scans are inconclusive, and if contrast-enhanced computed tomography (CT) and contrast enhanced-magnetic resonance imaging (MRI) respectively cannot be used.

The detection or exclusion of malignancy is the primary aim of diagnostic imaging of the liver. One important factor in selecting an imaging test is its ability to provide a rapid diagnosis, both to facilitate prompt treatment in patients who do have cancer and to minimise anxiety in the majority who do not (it is estimated that as many as 70-75% of liver lesions assessed in the NHS may be benign).

Sometimes when liver lesions are found with an initial unenhanced US scan, the liver abnormality cannot be characterised and the patient is then usually referred for additional imaging using MRI and/or CT. This may lead to waits of several months with consequent distress to patients and families. In addition, there are potential drawbacks in using these other imaging techniques; CT uses ionising radiation and the intravenous contrast agent can, on rare occasions, cause kidney damage and some patients cannot have an MRI scan due to pacemakers while others find the examination causes claustrophobia.

SonoVue is a second generation contrast agent and is licensed for contrast-enhanced ultrasound imaging in adults in whom unenhanced ultrasound is inconclusive. It uses sulphur hexafluoride microbubbles which are injected into the bloodstream to enhance the blood's ability to reflect ultrasound waves (echogenicity) and thus improve the signal to noise ratio in ultrasound. It improves display of the blood vessels in liver lesions during ultrasound scanning, allowing more specific characterisation of lesions.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Ultrasound scanning, along with other imaging technologies such as CT and MRI, are important in diagnosing and planning treatment for many patients with liver disease. One drawback with unenhanced liver imaging is that it sometimes identifies damage to the liver which cannot be characterised initially and another test may therefore be needed to fully explain the abnormality. One important potential benefit of SonoVue is that it can be carried out at the same appointment as the initial scan, thereby minimising any delay to diagnosis and subsequent treatment, with associated reduction in anxiety for patients and their families.

“The independent Diagnostics Advisory Committee concluded that the evidence presented showed that contrast-enhanced imaging with SonoVue is less costly and more effective compared to contrast-enhanced CT and MRI for characterising incidentally detected liver lesions. The Committee also concluded that SonoVue is an effective use of NHS resources in patients with suspected cancer of the liver that has spread from other cancers in the body and in patients with liver cirrhosis for whom CT scanning or MRI scanning respectively are not suitable.”

The diagnostics guidance for SonoVue is available from Wednesday 29 August.

Ends

Notes to Editors

About the guidance

1. The cost of SonoVue used in this assessment is £65, representing the cost of the SonoVue kit and the extra time required for the scan. This cost assumes that contrast-enhanced ultrasound with SonoVue is performed during the same appointment as the un-enhanced ultrasound.

2. Contrast-enhanced CT and/or contrast-enhanced MRI were the comparators used in this evaluation. These cost between £116 - £162 and £189 - £366 respectively, depending on how these tests were used in the population of interest.

3. Although primary liver cancer is rare in the UK (age-standardised rates are 4.7 per 100,000 men and 2.9 per 100,000 women), it is the second most rapidly increasing cancer in men and the third in women (increases of 38% and 28% respectively in the past decade).

4. Primary liver cancer in adults has a poor prognosis because it tends to be diagnosed in the advanced stages. Only a minority of cases of primary liver cancer are diagnosed in the early stages when surgery may help.

5. The prognosis of primary liver cancer is dependent on the extent of disease and underlying liver function. About 20% of people with a primary liver cancer live for at least 1 year after diagnosis. Around 5% live for at least 5 years.

6. The primary cancers most commonly leading to secondary cancers in the liver originate in the breast, lung and bowel (colorectal). The origin of the primary cancer is important because the cells of the secondary cancer in the liver will be the same as those of the primary cancer, and are likely to be treated according to the cell type of the primary cancer.

7. Approximately 90,000 people each year are diagnosed with liver metastases - cancer that has spread from another part of the body.

8. The prognosis of secondary liver cancer is dependent on the extent of the disease and patient co-morbidity. For example, 40 - 60% of people with stage 4 colorectal cancer (where the cancer has spread to another part of the body), with a resectable secondary cancer in the liver will live for 5 years after surgery.

9. NICE clinical guideline 131 on the diagnosis and treatment of colorectal cancer recommends the use of CT in patient staging and follow-up which includes the identification of liver metastases.

About the NICE Diagnostics Assessment Programme

10. Further information about the NICE diagnostics assessment programme.

11. Topics to be considered by the Programme are routed through the related Medical Technologies Assessment Programme.

About NICE

12. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

13. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

14. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

15. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.