Primary Hyperparathyroidism Clinical Trial
Official title:
Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery Using Quantitative Analysis of Scintigraphy Results on Hybrid SPECT-CT Imaging
Verified date | December 2022 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients - No history of thyroid or parathyroid surgery - Diagnosis of primary hyperparathyroidism - Indication for 99mTc-MIBI SPECT/CT examination Exclusion Criteria: - Minor patients - Negative SPECT/CT findings - Patients refusing surgery - Previous combined surgery on the thyroid gland - Patients in high risk of general anesthesia - Patients who do not undergo surgery in the recommended time span |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Primary | 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. | 3 months | |
Secondary | Operating time (minutes) | The operating time will be measured and recorded. | Duration of surgery | |
Secondary | Pathological parathyroid gland volume (ml) | The pathological parathyroid gland volume in millilitres will be measured and recorded. | Duration of surgery | |
Secondary | Pathological parathyroid gland localisation (ectopic x eutopic) | The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded. | Duration of surgery |
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