TY - JOUR
T1 - PET/CT in cancer: moderate sample sizes may suffice to justify replacement of a regional gold standard
AU - Gerke, Oke
AU - Poulsen, Mads Hvid
AU - Bouchelouche, Kirsten
AU - Høilund-Carlsen, Poul Flemming
AU - Vach, Werner
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
KW - Clinical Trials as Topic
KW - Humans
KW - Male
KW - Positron-Emission Tomography
KW - Prostatic Neoplasms
KW - Sample Size
KW - Sensitivity and Specificity
KW - Tomography, Emission-Computed
U2 - 10.1007/s11307-009-0224-1
DO - 10.1007/s11307-009-0224-1
M3 - Journal article
C2 - 19424758
SN - 1536-1632
VL - 11
SP - 381
EP - 385
JO - Molecular Imaging and Biology
JF - Molecular Imaging and Biology
IS - 6
ER -