The Move from Accuracy Studies to Randomized Trials in PET: Current Status and Future Directions

Article Figures & Data

TABLE 1

Selected Characteristics of Published Studies

						Sample size calculation
Study	Disease	Clinical situation	Primary outcome	Patient-important outcome	Comparator is current standard	Performed	Assumptions justified
Beanlands (2007) (21)	Coronary heart disease	Treatment planning	Composite clinical endpoint at 1 y	Yes	Yes (33)	Yes	For one arm
de Bree (2007) (14)	Laryngeal carcinoma	Follow-up	Futile indication for direct laryngoscopy	(Yes)	NA	Yes	For both arms
Fischer (2009) (25)	NSCLC	Staging	Futile thoracotomy	Yes	Yes (34,35)	Yes	No
Herder (2006) (20)	NSCLC	Staging	Number of diagnostic investigations	(No)	(Yes)^* (36)	Yes	For one arm
Maziak (2009) (17)	NSCLC	Staging	Correct upstaging of cancer	No	Yes (34,35)	Yes	For one arm
Monteil (2010) (19)	NSCLC	Follow-up	Recurrence or new tumor detected	No	Yes (36)	No	No
Mullani (2000) (16)	Coronary heart disease	Treatment planning	Positive scan	No	?	No	No
Plewnia (2007) (15)	Tinnitus	Treatment planning	Tinnitus distress measure	Yes	NA	No	No
Ruers (2009) (26)	Colorectal liver metastases	Staging	Futile laparotomy	Yes	(Yes) (37)	Yes	For one arm
Siebelink (2001) (22)	Coronary heart disease	Treatment planning	Cardiac event-free survival	Yes	?	Yes	For one arm
Sobhani (2008) (18)	Colorectal cancer	Follow-up	Recurrence after 9 and 15 mo of follow-up	No	Yes (38,39)	Yes	No
Tsai (2010) (23)	Cervical cancer	Treatment planning	Therapeutic outcomes (survival)	Yes	Yes (40)	No	No
van Tinteren (2002) (9)	NSCLC	Staging	Futile thoracotomy	Yes	Yes (36)	Yes	For both arms
Viney (2004) (24)	NSCLC	Staging	Thoracotomy avoided	Yes	Yes (36)	Yes	No

↵* Description was too incomplete for comparison with international guidelines, but authors claimed that it was “according to international guidelines.”
NA = not applicable; NSCLS = non–small cell lung cancer; ? = comparator could not be evaluated.
Parentheses around the words yes or no indicate an uncertain assessment.

TABLE 2

Effects to Be Assumed in Each Study to Reach Power of 90%

↵* Data are failure rate in control arm, number of patients in control arm and number in PET arm, and relative risk (RR) to be assumed.
↵† Data are number of events observed and number in overall sample, and hazard ratio (HR) to be assumed.
↵‡ Data are number of patients in control arm and number in PET arm, and Cohen d to be assumed. One study with crossover design (17) is not included in this table.
↵§ Assumptions are according to published study protocol.
↵║ Study reports success rate, which is transformed to failure rate.

TABLE 3

Selected Characteristics of Studies Found in Clinical Trial Registers

Register ID	Study register	Acronym	Disease	Clinical situation	Primary outcome	Patient-important primary outcome	First enrollment	Planned overall sample size
NCT00136864	WHO/ct.gov	PET-START	NSCLC	Treatment planning	Upstaging	No	Aug 2004	400
NCT00882609^*	ct.gov		Cancer (breast, prostate, lung)	Unclear	Diagnostic performance	No	Jan 2009	550
NCT00265356	WHO/ct.gov	PETCAM	CRC liver metastases	Staging/treatment planning	Change in management	No	Nov 2005	404
NCT00976053^*	ct.gov		CAD	Diagnostic (known CAD)	Diagnostic failure	No	June 2009	330
NCT00895349	ct.gov	PET LACE	Cervical cancer	Treatment planning	Treatment delivered	No	Apr 2010	288
NCT00964275	ct.gov		Cancer	Primary diagnosis	Cancer diagnosed	No	Mar 2009	310
NCT00169598	ct.gov	TEPELY	Lymphoma (HD, non-HD)	Unclear	Therapeutic prescription	No	Feb 2002	80
NCT00199654	ct.gov		CRC	Follow-up	Time to CRC relapse	(Yes)	Feb 2004	376
NCT01469026^*	ct.gov	CUP Project	CUP	Staging	Detection of primary tumor possible	No	Nov 2011	220
NCT00954148^*	ct.gov		Cancer	Follow-up	5-y survival, cost and time to identification of new disease	Yes	Sep 2009	53
NCT01170923	ct.gov		NSCLC	Treatment planning	Change in response rate	(Yes)	Sep 2008	100
NCT00720070	ct.gov	PET/CT	Head and neck cancer	Staging	Overall survival	Yes	Sep 2007	560
NCT00433433	ct.gov		Hodgkin lymphoma	Early response evaluation	Progression-free survival	Yes	Oct 2006	1,797
ACTRN12608000641392	WHO		Prostate cancer	Treatment planning	Change in management	No	Oct 2008	100
ISRCTN49573946	ISRCTN	BOOST	Lung cancer	Primary diagnosis/staging	Time to treatment decision	No	April 2008	168

↵* Studies not included in review by Scheibler et al. (10).
WHO = International Clinical Trials Registry (World Health Organization); ct.gov = clinicaltrials.gov; NSCLC = non–small cell lung cancer; CAD = coronary artery disease; HD = Hodgkin disease; CRC = colorectal cancer; CUP = cancer of unknown primary.
Parentheses around the words yes or no indicate an uncertain assessment.