ABSTRACT
Objective: The extent of symptoms due to primary hyperparathyroidism (PHPT) depends on the population being studied. PHPT is mainly discovered incidentally through routine laboratory findings. Less is known about patient-experienced improvement following successful parathyroidectomy. The aim of our study was to assess the changes in the quality of life (QoL) after successful surgery using an SF-36 questionnaire. Design: This is a prospective cohort study based on questionnaires. Methods: Forty consecutive patients diagnosed with PHPT were prospectively administered an SF-36 questionnaire before and 6 months after successful parathyroidectomy. A subgroup of 18 patients answered the questionnaire at 1 and 3 months after surgery. Successful surgery was based on biochemistry and pathology reports as confirmed by an endocrinologist. Results of each SF-36 subcategory were compared to the results at baseline in order to detect changes in patient-reported QoL after successful surgery. Results: There were significant improvements in six of eight SF-36 subcategories: vitality (P = 0.0001), physical functioning (P = 0.04), general health perception (P = 0.004), physical role functioning (P = 0.04), social role functioning (P = 0.004), and mental health perception (P = 0.0001). Changes appeared within a month after surgery with no further significant changes at later time points. Conclusions: Parathyroidectomy significantly improves QoL as measured by a decrease in SF-36 scores as early as 1 month after successful parathyroidectomy. The SF-36 QoL questionnaire is suitable for monitoring changes in patient well-being after successful parathyroidectomy.
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).
ABSTRACT
BACKGROUND: In patients with primary hyperparathyroidism (PHPT) locating hyperfunctioning glands (HPGs) is crucial when planning minimally invasive surgery. Dual-isotope subtraction scintigraphy with 99mTc-MIBI/123Iodide using SPECT/CT and planar pinhole imaging (Method A) has previously shown a sensitivity >93%. However, the method is costly and time consuming and entails a high radiation dose. 11C-Choline PET/CT (Method B) is an appealing candidate method unencumbered by these disadvantages. METHODS: Sixty patients with newly diagnosed PHPT participated and were scanned using both methods prior to parathyroidectomy. We investigated whether sensitivities of Method A and Method B are similar in a method-to-method comparison when using surgical findings as the true location. RESULTS: At the patient level, sensitivities were (A) 0.98 (95% CI: 0.90-1.00) and (B) 1.00 (95% CI: 0.93-1.00). At the gland level, sensitivities were (A) 0.88 (95% CI: 0.78-0.94) and (B) 0.87 (95% CI: 0.76-0.92). With a non-inferiority margin of ∆ = -0.1, we found a 1-sided p-value < 0.001. CONCLUSION: Our methods comparison study found that sensitivity of Method B was not inferior to Method A. We suggest that 11C-Choline PET/CT is a clinically relevant first-choice candidate for preoperative imaging of PHPT and that Method B can likely replace Method A in the near future.
ABSTRACT
BACKGROUND: Adding subtraction single-photon emission computed tomography/computed tomography (SPECT/CT) to dual isotope (I-123 and Tc-99m-sestamibi) subtraction parathyroid scintigraphy is not widely implemented. We aimed to assess the added value of dual isotope subtraction SPECT/CT over single isotope SPECT/CT as an adjunct to dual isotope planar pinhole subtraction scintigraphy. METHODS: Parathyroid scintigraphies from 106 patients with an estimated total of 415 parathyroid glands who (1) were diagnosed with primary hyperparathyroidism, (2) underwent dual isotope subtraction scintigraphy in the Department of Nuclear Medicine, Gentofte Hospital, Denmark throughout 2017 and (3) underwent subsequent parathyroidectomy, were included. The original dual isotope planar pinhole subtraction plus dual isotope subtraction SPECT/CT (dual/dual method) exams were retrospectively re-evaluated using only Tc-99m-sestamibi SPECT/CT (dual/single method). Statistics were calculated per parathyroid. Surgical results confirmed by pathology served as reference standard. RESULTS: The dual/dual method had higher sensitivity than the dual/single method (82% (95%CI 74%-88%) vs. 69% (95%CI 60%-77%)) while specificity, positive and negative predictive values (PPV and NPV) were similar (specificity 96% vs. 93%, PPV's 87% vs. 82% and NPV's 89% vs. 93%). Reader confidence was higher when employing the dual/dual method (p = 0.001). CONCLUSIONS: The dual/dual method can be considered superior to the dual/single method in the preoperative imaging in primary hyperparathyroidism.
