PET/CT in cancer: moderate sample sizes may suffice to justify replacement of a regional gold standard

Oke Gerke, Mads Hvid Poulsen, Kirsten Bouchelouche, Poul Flemming Høilund-Carlsen, Werner Vach

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: null-null
OriginalsprogEngelsk
TidsskriftMolecular Imaging and Biology
Vol/bind11
Udgave nummer6
Sider (fra-til)381-5
Antal sider4
ISSN1536-1632
DOI
StatusUdgivet - 2009

Fingeraftryk

Sample Size
Neoplasms
Prostatic Neoplasms
Positron Emission Tomography Computed Tomography

Citer dette

@article{991f76d009de11dfaefb000ea68e967b,
title = "PET/CT in cancer: moderate sample sizes may suffice to justify replacement of a regional gold standard",
abstract = "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.",
keywords = "Clinical Trials as Topic, Humans, Male, Positron-Emission Tomography, Prostatic Neoplasms, Sample Size, Sensitivity and Specificity, Tomography, Emission-Computed",
author = "Oke Gerke and Poulsen, {Mads Hvid} and Kirsten Bouchelouche and H{\o}ilund-Carlsen, {Poul Flemming} and Werner Vach",
year = "2009",
doi = "10.1007/s11307-009-0224-1",
language = "English",
volume = "11",
pages = "381--5",
journal = "Molecular Imaging and Biology",
issn = "1536-1632",
publisher = "Springer",
number = "6",

}

PET/CT in cancer: moderate sample sizes may suffice to justify replacement of a regional gold standard. / Gerke, Oke; Poulsen, Mads Hvid; Bouchelouche, Kirsten; Høilund-Carlsen, Poul Flemming; Vach, Werner.

I: Molecular Imaging and Biology, Bind 11, Nr. 6, 2009, s. 381-5.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

VL - 11

SP - 381

EP - 385

JO - Molecular Imaging and Biology

JF - Molecular Imaging and Biology

SN - 1536-1632

IS - 6

ER -