An interventional study of Conventional (dual-phase) SPECT/CT and Multi-phase SPECT/CT in Primary Hyperparathyroidism, Thyroid Disease and Parathyroid Diseases, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.
Despite the relatively accurate preoperative topographic information, minimally invasive parathyroid surgery can still be very challenging, especially in the case of small adenoma in ectopic localization. Radioguided technique offers both help with in-vivo identification and ex-vivo confirmation of adenoma. Excellent ex-vivo radio guidance results are referred. But, in-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's enrollment of 100 is above the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
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Exclusion Criteria:
Adult patients with primary hyperparathyroidism undergoing conventional (dual-phase) SPECT/CT (after 10 and 150 minutes) and conventional minimally-invasive radio-guided parathyroidectomy in a time span 2-3 hours from radionuclide administration.
Procedure: Conventional (dual-phase) SPECT/CT · Procedure: Conventional minimally-invasive radio-guided parathyroidectomy
Adult patients with primary hyperparathyroidism undergoing multi-phase SPECT/CT (after 10, 90, 150, 210 minutes) and individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
Procedure: Multi-phase SPECT/CT · Procedure: Individualised minimally-invasive radio-guided parathyroidectomy
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
Success of surgery (%)
Surgery was considered successful if there were lowering of parathyroid hormone serum level and calcemia to normal and histological confirmation of parathyroid gland adenoma/ hyperplasia.
Time frame: 3 months
In-vivo sensitivity (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.
Time frame: 3 months
In-vivo specificity (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.
Time frame: 3 months
In-vivo accuracy (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. The parathyroid tissue was considered pathologic when the in-vivo radioactive counting was at least 1.15 times more than the background.
Time frame: 3 months
Ex-vivo sensitivity (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Time frame: 3 months
Ex-vivo specificity (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Time frame: 3 months
Ex-vivo accuracy (%)
Calculated from number of true positive, false positive, true negative and false negative cases identified by gamma probe during surgery. Radioactive ex-vivo counts in adenoma/ hyperplastic parathyroid gland greater than 20% of background was used as cutpoint for cure.
Time frame: 3 months
Operating time (minutes)
The operating time will be measured and recorded.
Time frame: Duration of surgery
Pathological parathyroid gland volume (ml)
The pathological parathyroid gland volume in millilitres will be measured and recorded.
Time frame: Duration of surgery
Pathological parathyroid gland localisation (ectopic x eutopic)
The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Time frame: Duration of surgery
Plan to share: No — Individual participant data will be made available to other researchers upon request.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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