Julie Wulf Christensen1, Lars Thorbjørn Jensen2, Susanne Bonnichsen Søndergaard2, Rikke Broholm2, Christian Haarmark2, Martin Krakauer2,3, Finn Noe Bennedbæk4, Bo Zerahn2, Waldemar Trolle5, Christoffer Holst Hahn6, Bent Kristensen2. 1. Department of Nuclear Medicine, Herlev and Gentofte Hospital, 2730, Herlev, Denmark. juliewulfc@gmail.com. 2. Department of Nuclear Medicine, Herlev and Gentofte Hospital, 2730, Herlev, Denmark. 3. Department of Clinical Physiology and Nuclear Medicine, Bispebjerg and Frederiksberg Hospital, 2400, Copenhagen, Denmark. 4. Department of Medicine, Division of Endocrinology, Herlev and Gentofte Hospital, 2730, Herlev, Denmark. 5. Department of Otorhinolaryngology and Neck Surgery, North Zealand Hospital, 3400, Hilleroed, Denmark. 6. Department of Otorhinolaryngology and Neck Surgery, Rigshospitalet, 2100, Copenhagen, Denmark.
Abstract
BACKGROUND: Use of 11C-Choline PET/CT is gaining ground in detecting hyperfunctioning parathyroid glands in primary hyperparathyroidism. The purpose of this study was to evaluate the robustness of 11C-Choline PET/CT by assessing intra- and inter-observer agreement to determine whether the method was reader sensitive and therefore should only be performed at highly specialised sites with a high number of cases. PET/CT images of 40 patients diagnosed with primary hyperparathyroidism were anonymised and evaluated three times by three readers: an expert reader and two non-experts (non-experts were experienced in PET/CT imaging, but not in 11C-Choline PET/CT in the setting of primary hyperparathyroidism). Number of hyperfunctioning parathyroid glands, location relative to the thyroid gland and confidence of each assessment (low, moderate or high) were noted, and intra- and inter-observer agreement calculated using Fleiss' kappa method. Sensitivities and specificities of the non-experts were calculated using the expert reader as gold standard. RESULTS: Intra-observer agreement was 'good' to 'near perfect' for all readers. Inter-observer agreement was good between non-experts and the expert, with kappa values ≥ 0.74. Sensitivities between non-experts and the expert were high, > 81%, when assessing which side and 75% when assessing thyroid quadrant. All specificities were > 94%. Reader certainties were 'high' in > 80% of cases for the expert and > 70% and > 65%, respectively for the two non-experts. CONCLUSION: 11C-Choline PET/CT is not reader sensitive for the localisation of hyperfunctioning parathyroid glands and may therefore be safely implemented at sites that have a moderate number of cases. Access to a cyclotron laboratory is, however, a necessity for the production of 11C-Choline. The study was conducted in accordance with the Helsinki 2 declaration and The International Council for Harmonisation Guideline for Good Clinical Practice (ICH_GCP) clinical trial, approved by the Research Ethics Committee of the Capital Region of Denmark (Journal-nr.:H-18012490, date of approval: 18 June 2018) and the Danish Medicines Agency (EudraCT no. 2018-000726-63, date of approval: 6 June 2018). The GCP unit in Eastern Denmark has carried out regular monitoring of the trial according to GCP (ID: 2018-1050).
BACKGROUND: Use of 11C-Choline PET/CT is gaining ground in detecting hyperfunctioning parathyroid glands in primary hyperparathyroidism. The purpose of this study was to evaluate the robustness of 11C-Choline PET/CT by assessing intra- and inter-observer agreement to determine whether the method was reader sensitive and therefore should only be performed at highly specialised sites with a high number of cases. PET/CT images of 40 patients diagnosed with primary hyperparathyroidism were anonymised and evaluated three times by three readers: an expert reader and two non-experts (non-experts were experienced in PET/CT imaging, but not in 11C-Choline PET/CT in the setting of primary hyperparathyroidism). Number of hyperfunctioning parathyroid glands, location relative to the thyroid gland and confidence of each assessment (low, moderate or high) were noted, and intra- and inter-observer agreement calculated using Fleiss' kappa method. Sensitivities and specificities of the non-experts were calculated using the expert reader as gold standard. RESULTS: Intra-observer agreement was 'good' to 'near perfect' for all readers. Inter-observer agreement was good between non-experts and the expert, with kappa values ≥ 0.74. Sensitivities between non-experts and the expert were high, > 81%, when assessing which side and 75% when assessing thyroid quadrant. All specificities were > 94%. Reader certainties were 'high' in > 80% of cases for the expert and > 70% and > 65%, respectively for the two non-experts. CONCLUSION:11C-Choline PET/CT is not reader sensitive for the localisation of hyperfunctioning parathyroid glands and may therefore be safely implemented at sites that have a moderate number of cases. Access to a cyclotron laboratory is, however, a necessity for the production of 11C-Choline. The study was conducted in accordance with the Helsinki 2 declaration and The International Council for Harmonisation Guideline for Good Clinical Practice (ICH_GCP) clinical trial, approved by the Research Ethics Committee of the Capital Region of Denmark (Journal-nr.:H-18012490, date of approval: 18 June 2018) and the Danish Medicines Agency (EudraCT no. 2018-000726-63, date of approval: 6 June 2018). The GCP unit in Eastern Denmark has carried out regular monitoring of the trial according to GCP (ID: 2018-1050).
Authors: Tessa S S Genders; Sandra Spronk; Theo Stijnen; Ewout W Steyerberg; Emmanuel Lesaffre; M G Myriam Hunink Journal: Radiology Date: 2012-10-23 Impact factor: 11.105
Authors: William C Lavely; Sibyll Goetze; Kent P Friedman; Jeffrey P Leal; Zhe Zhang; Elizabeth Garret-Mayer; Alan P Dackiw; Ralph P Tufano; Martha A Zeiger; Harvey A Ziessman Journal: J Nucl Med Date: 2007-06-15 Impact factor: 10.057
Authors: Milou E Noltes; Schelto Kruijff; Walter Noordzij; Eef D Telenga; David Vállez García; Malgorzata Trofimiuk-Müldner; Marta Opalińska; Alicja Hubalewska-Dydejczyk; Gert Luurtsema; Rudi A J O Dierckx; Mostafa El Moumni; Ronald Boellaard; Adrienne H Brouwers Journal: EJNMMI Res Date: 2019-07-31 Impact factor: 3.138
Authors: Julie Wulf Christensen; Karin Folmer Thøgersen; Lars Thorbjørn Jensen; Martin Krakauer; Bent Kristensen; Finn Noe Bennedbæk; Bo Zerahn Journal: Endocr Connect Date: 2022-03-31 Impact factor: 3.221