% IMPORTANT: The following is UTF-8 encoded.  This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.

@ARTICLE{Hahner:301514,
      author       = {S. Hahner and P. Hartrampf and F. Beuschlein and M.
                      Miederer and K. Miehle and W. Schlötelburg and C. T. Fuß
                      and T. Pfluger and C. Fottner and A. Tönjes and K.
                      Herrmann$^*$ and H. Amthauer and M. Reincke and M.
                      Schreckenberger and O. Sabri and J. Werner and M. Reuter and
                      S. Kircher and W. Arlt and M. Fassnacht and A. Konrad Buck
                      and H.-H. Müller and A. Schirbel},
      collaboration = {F. investigators},
      othercontributors = {C. Furth and K. Mai and M. Quinkler and F. Weber and H.
                          Dralle and B. Sandner and T. Lincke and R. Kluge and N.
                          Rayes and M. Weber and M. Gräsl and W. Saeger and J.
                          Reibetanz},
      title        = {{C}ombined [18{F}]{F}luorodeoxyglucose {PET} and
                      [123{I}]{I}odometomidate-{SPECT} for diagnostic evaluation
                      of indeterminate adrenal neoplasias-the cross-sectional
                      diagnostic test accuracy study {FAMIAN}.},
      journal      = {EBioMedicine},
      volume       = {116},
      issn         = {2352-3964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2025-01051},
      pages        = {105735},
      year         = {2025},
      abstract     = {Adrenal tumours are frequently detected by conventional
                      imaging. However, computed tomography and magnet resonance
                      imaging have limited specificity in classifying the most
                      prevalent tumour type, adrenocortical adenoma (ACA), which
                      typically does not require surgery. We proposed that
                      combined molecular imaging with
                      [18F]Fluorodeoxyglucose-positron emission tomography (FDG
                      PET) and [123I]Iodometomidate-single photon emission
                      tomography (IMTO SPECT) improves non-invasive classification
                      of ACA.This cross-sectional, multicentre diagnostic study
                      included patients (≥30 years) with non-functioning
                      indeterminate adrenal masses (>3 cm or increase >1 cm,
                      Hounsfield units [HU] ≥10 on unenhanced computed
                      tomography [CT]) scheduled for surgery. Using histopathology
                      as the reference, we assessed the accuracy of FDG/IMTO
                      imaging as an ACA-test, assuming that low FDG with high IMTO
                      uptake is indicative of ACA, with a focus on high
                      specificity and moderate to high sensitivity. We also
                      investigated its accuracy in detecting or excluding
                      adrenocortical carcinoma (ACC) and evaluated FDG and
                      unenhanced CT in assessing malignancy.EudraCT
                      2012-003604-13; ClinicalTrials.gov-identifier
                      NCT02010957.From July 2015 to December 2020, 85 patients
                      were enrolled, with 77 included in the final analysis (53
                      benign, 30 ACA, 9 ACC). FDG/IMTO-imaging classified ACA with
                      high specificity $(95·7\%$ $[95\%$ CI $85·2\%-99·47\%]),$
                      high positive predictive value $(87·5\%$ $[95\%$ CI
                      $61·7\%-98·4\%])$ and high positive likelihood ratio
                      (11·1 $[95\%$ CI 3·2-122]). However, sensitivity was low
                      $(48·3\%$ $[95\%$ CI $29·4\%-67·5\%])$ due to
                      moderate/high FDG uptake in 14 of 30 ACA. Malignant masses
                      were classified with high sensitivity but low-to-moderate
                      specificity by both unenhanced CT (cut-off HU ≥20
                      sensitivity $100\%$ $[95\%$ CI $85·8\%-100\%],$ specificity
                      $26·4\%$ $[95\%$ CI $15·3\%-40·3\%])$ and FDG (visual
                      analysis sensitivity $95·8\%$ $[95\%$ CI
                      $78·9\%-99·9\%],$ specificity $62·3\%$ $[95\%$ CI
                      $47·9\%-75·2\%]).$ All four study-related AEs were grade
                      1, the seven serious AEs were not study-related.Combined
                      FDG/IMTO-imaging classifies ACA with high specificity,
                      potentially reducing unnecessary surgery. A sub-group of
                      FDG-positive ACA lowers sensitivity.German Research
                      Foundation and EU-FP7.},
      keywords     = {Adrenal incidentaloma (Other) / Adrenocortical adenoma
                      (Other) / Adrenocortical carcinoma (Other) / Computed
                      tomography (Other) / Fluorodeoxyglucose positron emission
                      tomography (Other) / Indeterminate adrenal masses (Other) /
                      Iodometomidate SPECT (Other) / Molecular imaging (Other)},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40398350},
      doi          = {10.1016/j.ebiom.2025.105735},
      url          = {https://inrepo02.dkfz.de/record/301514},
}