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Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial

PURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prereq... Full description

Journal Title: European journal of nuclear medicine and molecular imaging 2015, Vol.42 (6), p.848-857
Main Author: Hristova, I.N
Other Authors: Boellaard, R , Vogel, W , Mottaghy, F , Marreaud, S , Collette, S , Schoffski, P , Sanfilippo, R , Dewji, R , Graaf, W.T.A. van der , Oyen, W.J.G
Format: Electronic Article Electronic Article
Language: English
Subjects:
PET
Publisher: Berlin/Heidelberg: Springer Berlin Heidelberg
ID: ISSN: 1619-7070
Link: https://www.ncbi.nlm.nih.gov/pubmed/25711176
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4382532
title: Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial
format: Article
creator:
  • Hristova, I.N
  • Boellaard, R
  • Vogel, W
  • Mottaghy, F
  • Marreaud, S
  • Collette, S
  • Schoffski, P
  • Sanfilippo, R
  • Dewji, R
  • Graaf, W.T.A. van der
  • Oyen, W.J.G
subjects:
  • Cardiology
  • Clinical trials
  • Clinical Trials, Phase III as Topic
  • Dextrose
  • Fluorodeoxyglucose F18 - standards
  • Glucose
  • Guidelines
  • Guidelines as Topic
  • Harmonization
  • Humans
  • Imaging
  • Medical imaging
  • Medicine
  • Medicine & Public Health
  • Multicenter clinical study
  • Multicenter Studies as Topic
  • Nuclear Medicine
  • Oncology
  • Original
  • Original Article
  • Orthopedics
  • PET
  • PET imaging
  • Placebo effect
  • Positron-Emission Tomography - methods
  • Positron-Emission Tomography - standards
  • Product development
  • Quality assurance
  • Quality Control
  • Quantitative imaging biomarker
  • Radiology
  • Radiopharmaceuticals - standards
  • Randomized Controlled Trials as Topic
  • Retrospective review
  • Sarcoma - diagnostic imaging
  • Soft Tissue Neoplasms - diagnostic imaging
  • Standartization
ispartof: European journal of nuclear medicine and molecular imaging, 2015, Vol.42 (6), p.848-857
description: PURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 +/- 0.33 at baseline and 2.27 +/- 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 +/- 1.04 at baseline and 2.18 +/- 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
language: eng
source:
identifier: ISSN: 1619-7070
fulltext: no_fulltext
issn:
  • 1619-7070
  • 1619-7089
url: Link


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titleRetrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial
creatorHristova, I.N ; Boellaard, R ; Vogel, W ; Mottaghy, F ; Marreaud, S ; Collette, S ; Schoffski, P ; Sanfilippo, R ; Dewji, R ; Graaf, W.T.A. van der ; Oyen, W.J.G
creatorcontribHristova, I.N ; Boellaard, R ; Vogel, W ; Mottaghy, F ; Marreaud, S ; Collette, S ; Schoffski, P ; Sanfilippo, R ; Dewji, R ; Graaf, W.T.A. van der ; Oyen, W.J.G
descriptionPURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 +/- 0.33 at baseline and 2.27 +/- 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 +/- 1.04 at baseline and 2.18 +/- 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
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languageeng
publisherBerlin/Heidelberg: Springer Berlin Heidelberg
subjectCardiology ; Clinical trials ; Clinical Trials, Phase III as Topic ; Dextrose ; Fluorodeoxyglucose F18 - standards ; Glucose ; Guidelines ; Guidelines as Topic ; Harmonization ; Humans ; Imaging ; Medical imaging ; Medicine ; Medicine & Public Health ; Multicenter clinical study ; Multicenter Studies as Topic ; Nuclear Medicine ; Oncology ; Original ; Original Article ; Orthopedics ; PET ; PET imaging ; Placebo effect ; Positron-Emission Tomography - methods ; Positron-Emission Tomography - standards ; Product development ; Quality assurance ; Quality Control ; Quantitative imaging biomarker ; Radiology ; Radiopharmaceuticals - standards ; Randomized Controlled Trials as Topic ; Retrospective review ; Sarcoma - diagnostic imaging ; Soft Tissue Neoplasms - diagnostic imaging ; Standartization
ispartofEuropean journal of nuclear medicine and molecular imaging, 2015, Vol.42 (6), p.848-857
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4Marreaud, S
5Collette, S
6Schoffski, P
7Sanfilippo, R
8Dewji, R
9Graaf, W.T.A. van der
10Oyen, W.J.G
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0Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial
1European journal of nuclear medicine and molecular imaging
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0Eur J Nucl Med Mol Imaging
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descriptionPURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 +/- 0.33 at baseline and 2.27 +/- 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 +/- 1.04 at baseline and 2.18 +/- 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
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1Clinical trials
2Clinical Trials, Phase III as Topic
3Dextrose
4Fluorodeoxyglucose F18 - standards
5Glucose
6Guidelines
7Guidelines as Topic
8Harmonization
9Humans
10Imaging
11Medical imaging
12Medicine
13Medicine & Public Health
14Multicenter clinical study
15Multicenter Studies as Topic
16Nuclear Medicine
17Oncology
18Original
19Original Article
20Orthopedics
21PET
22PET imaging
23Placebo effect
24Positron-Emission Tomography - methods
25Positron-Emission Tomography - standards
26Product development
27Quality assurance
28Quality Control
29Quantitative imaging biomarker
30Radiology
31Radiopharmaceuticals - standards
32Randomized Controlled Trials as Topic
33Retrospective review
34Sarcoma - diagnostic imaging
35Soft Tissue Neoplasms - diagnostic imaging
36Standartization
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titleRetrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial
authorHristova, I.N ; Boellaard, R ; Vogel, W ; Mottaghy, F ; Marreaud, S ; Collette, S ; Schoffski, P ; Sanfilippo, R ; Dewji, R ; Graaf, W.T.A. van der ; Oyen, W.J.G
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1Clinical trials
2Clinical Trials, Phase III as Topic
3Dextrose
4Fluorodeoxyglucose F18 - standards
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6Guidelines
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8Harmonization
9Humans
10Imaging
11Medical imaging
12Medicine
13Medicine & Public Health
14Multicenter clinical study
15Multicenter Studies as Topic
16Nuclear Medicine
17Oncology
18Original
19Original Article
20Orthopedics
21PET
22PET imaging
23Placebo effect
24Positron-Emission Tomography - methods
25Positron-Emission Tomography - standards
26Product development
27Quality assurance
28Quality Control
29Quantitative imaging biomarker
30Radiology
31Radiopharmaceuticals - standards
32Randomized Controlled Trials as Topic
33Retrospective review
34Sarcoma - diagnostic imaging
35Soft Tissue Neoplasms - diagnostic imaging
36Standartization
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8Dewji, R
9Graaf, W.T.A. van der
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atitleRetrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial
jtitleEuropean journal of nuclear medicine and molecular imaging
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abstractPURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 +/- 0.33 at baseline and 2.27 +/- 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 +/- 1.04 at baseline and 2.18 +/- 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
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