NCT01881620: COMBITEP

PET Enhanced CT Scan Performance in Cancer

Completed NA Results posted Last updated 18 November 2024

What this trial tests

NA trial testing COMBI TEP : PET / enhanced CT scan in Cancer Disease Progression in 109 participants. Completed in 15 July 2015.

Timeline

19 March 2010

Primary endpoint
19 July 2012

15 July 2015

Quick facts

Lead sponsor	Institut Bergonié
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	109
Start date	19 March 2010
Primary completion	19 July 2012
Estimated completion	15 July 2015

Drugs / interventions tested

• COMBI TEP : PET / enhanced CT scan

Conditions studied

• Cancer Disease Progression — all drugs for Cancer Disease Progression →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Cancer Disease Progression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions Primary · 1 year

The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer rep

Thorax region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7254	0.6288 – 0.8220

Abdomen region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7854	0.6923 – 0.8784

Pelvis region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7597	0.6408 – 0.8787

Bone region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.6711	0.4239 – 0.9183

Nervous system region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	1	1 – 1

Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level Secondary · 1 year

The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.6528	0.5194 – 0.7863

Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions Secondary · 1 year

For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of indepen

Thorax region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.8526	0.7733 – 0.9319

Abdomen region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.8153	0.7118 – 0.9187

Pelvis region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7452	0.6020 – 0.8885

Bone region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.8722	0.7269 – 1.0000

Nervous system region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	1	1 – 1

Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level Secondary · 1 year

The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient \[ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates a

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7859	0.6561 – 0.9157

Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions Secondary · 1 year

For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed be

Thorax region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.8141	0.7129 – 0.9153

Abdomen region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7991	0.6951 – 0.9032

Pelvis region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7947	0.6326 – 0.9568

Bone region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	-0.0095	-0.0227 – 0.0037

Nervous system region

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	1	1 – 1

Intra-observer Reproducibility of Injected CT Scanat a Patient Level Secondary · 1 year

The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpret

Group	Value	95% CI
COMBI TEP : PET / Enhanced CT Scan	0.7984	0.6708 – 0.9260

Sponsor's own description

Hypothesis:

The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.

This study is a prospective single center study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ECR 2016 Book of Abstracts - B - Scientific Sessions and Clinical Trials in Radiology.
   · 2016 · cited 1× · PMID 26873358 · DOI 10.1007/s13244-016-0475-8