Authors' objectives:

The clinical effectiveness of FDG positron emission tomography (PET) has been assessed previously for six indications (lung cancer, metastatic melanoma, malignant glioma, colorectal cancer, refractory epilepsy, and myocardial viability (Medical Services Advisory Committee 2000). The current review assesses an additional five clinical questions.

The areas covered are: - Assessment of patients with suspected recurrent ovarian carcinoma and equivocal conventional imaging; - Assessment of patients with; 1) cervical, or 2) endometrial carcinoma for staging of disease prior to planned radical radiation therapy or combined modality therapy; - Assessment of patients with oesophageal carcinoma for staging of disease where surgery or chemoradiation is planned; - Assessment of patients with gastric cancer for staging of disease where curative surgery is planned.

Authors' results and conclusions: Safety: It is generally accepted that PET is a noninvasive and relatively safe diagnostic procedure. Safety issues are primarily discussed in terms of the safety of the positronemitting radiopharmaceutical, rather than the safety of the procedure as a whole. In a large study of 22 FDG PET centres in the United States no adverse reactions to positron-emitting radiopharmaceuticals were reported for 33,295 retrospective doses of positron-emitting radiopharmaceuticals from before 1994 or 47,876 prospective doses from 1994 to 1997. The United States Pharmacopoeia (USP) drug information for FDG also indicates that there are no known adverse effects associated with the use of FDG. In addition, radiotracers are generally used in microgram quantities, and the incidence of adverse reactions to very small amounts of labelled molecules is likely to continue to be low. Diagnostic accuracy: PET has improved diagnostic accuracy over conventional imaging in a number of indications. PET has demonstrated improved detection over conventional imaging of recurrent disease in patients with ovarian carcinoma. PET also has good diagnostic accuracy for the detection of nodal and distant metastatic involvement in the pretreatment staging of patients with cervical carcinoma, oesophageal carcinoma and gastric or gastro-oesophageal carcinoma. However, as with other imaging modalities, PET still has low sensitivity for the detection of early (ie low volume or microscopic) metastatic disease. In each of these examples, PET has demonstrated improvements in diagnostic accuracy; however, the degree of improvement is sometimes difficult to quantify because of potential issues in the way in which patients were selected for studies or the information used to direct how reference standards were performed.

Authors' recommendations: MSAC concludes that, with respect to the indications reviewed, there is insufficient evidence at this time on PETs clinical effectiveness or cost-effectiveness to warrant unrestricted Medicare funding. While unrestricted funding is not warranted at this time, the evidence suggests that FDG PET is safe, has good diagnostic accuracy and is potentially clinically effective and potentially cost-effective in the indications reviewed. On this basis MSAC recommends that FDG PET be funded on an interim basis for the following clinical scenarios: - A whole body PET study, performed in a patient following initial therapy for epithelial ovarian carcinoma with suspected tumour recurrence based on equivocal anatomical imaging findings or an elevation of CA 125; - A whole body PET study, performed in a woman with a pathological diagnosis of primary carcinoma of the uterine cervix, for staging the disease prior to planned radical radiation therapy or combined modality therapy; - A whole body PET study, performed for staging of a patient with proven oesophageal carcinoma where curative surgery or chemoradiation is planned; and - A whole body PET study, performed for staging of a patient with proven gastric cancer where curative surgery is planned.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/reports.htm

Year Published: 2001

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)