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PET/CT in cancer: moderate sample sizes may suffice to justify replacement of a regional gold standard
Oke Gerke1, Mads Hvid Poulsen, Kirsten Bouchelouche
1Department of Nuclear Medicine, Odense University Hospital, Odense C, Denmark. oke@stat.sdu.dk
Purpose:
For certain cancer indications, the current patient evaluation strategy is a perfect but locally restricted gold standard procedure. If positron emission tomography/computed tomography (PET/CT) can be shown to be reliable within the gold standard region and if it can be argued that PET/CT also performs well in adjacent areas, then sample sizes in accuracy studies can be reduced.
Procedures:
Traditional standard power calculations for demonstrating sensitivities of both 80% and 90% are shown. The argument is then described in general terms and demonstrated by an ongoing study of metastasized prostate cancer.
Results:
An added value in accuracy of PET/CT in adjacent areas can outweigh a downsized target level of accuracy in the gold standard region, justifying smaller sample sizes.
Conclusions:
If PET/CT provides an accuracy benefit in adjacent regions, then sample sizes can be reduced and the conduct of trials accelerated, leading to earlier decisions on the use of PET/CT while exposing fewer patients and reducing overall costs.
