Evidence map›Paper›PMID 25711176›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2015

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.

Ivalina Hristova, Ronald Boellaard, Wouter Vogel, Felix Mottaghy, Sandrine Marreaud, Sandra Collette, Patrick Schöffski, Roberta Sanfilippo, Raz Dewji, Winette van der Graaf and 1 more

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 23 citations in OpenAlex.

  1. Mitigating SUV uncertainties using total body PET imaging.European journal of nuclear medicine and molecular imaging · 2024
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  2. Review
  3. The imaging quantification of multiple organs by dynamicInternational journal of medical sciences · 2022
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  4. Test-retest repeatability of [Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2020
    Article
  5. Review
  6. Article
  7. EANM/EARL FDG-PET/CT accreditation - summary results from the first 200 accredited imaging systems.European journal of nuclear medicine and molecular imaging · 2018
    Article
  8. Quantification: there is more to worry about than good scanner hardware and reliable calibration.European journal of nuclear medicine and molecular imaging · 2017
    Article
  9. Article
  10. Using PET for therapy monitoring in oncological clinical trials: challenges ahead.European journal of nuclear medicine and molecular imaging · 2017
    Review
  11. Repeatability of SUV in OncologicJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2017
    Review
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 4 countries.

Ivalina HristovaEuropean Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium, ivalinahr@gmail.com.
Ronald Boellaard
Wouter Vogel
Felix Mottaghy
Sandrine Marreaud
Sandra Collette
Patrick Schöffski
Roberta Sanfilippo
Raz Dewji
Winette van der Graaf
Wim J G Oyen
European Organisation for Research and Treatment of Cancer · BEAmsterdam UMC Location VUmc · NLFondazione IRCCS Istituto Nazionale dei Tumori · ITGlaxoSmithKline (United Kingdom) · GBKU Leuven · BEMaastricht University · NLRadboud University Medical Center · NLRadboud University Nijmegen · NLThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

methodsForty-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].

resultsOf 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.

conclusionThe 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.

Indexed as

Guidelines as TopicClinical Trials, Phase III as TopicFluorodeoxyglucose F18HumansMulticenter Studies as TopicPositron-Emission TomographyQuality ControlRadiopharmaceuticalsRandomized Controlled Trials as TopicSarcomaSoft Tissue NeoplasmsFluorodeoxyglucose F18Radiopharmaceuticals

Identifiers

PMID25711176
PMCPMC4382532
OpenAlexW2004468011

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.