Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Primary Hyperparathyroidism, Thyroid Disease, Parathyroid Diseases, Parathyroid Adenoma

Intervention / Treatment
-----------------
* Procedure: Conventional (dual-phase) SPECT/CT
* Procedure: Multi-phase SPECT/CT
* Procedure: Conventional minimally-invasive radio-guided parathyroidectomy
* Procedure: Individualised minimally-invasive radio-guided parathyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients are randomized into two parallel study arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional (dual-phase) SPECT/CT<br>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<br>* Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)<br>Procedure: Conventional minimally-invasive radio-guided parathyroidectomy<br>* Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration<br>|
| Experimental: Multi-phase SPECT/CT<br>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<br>* Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)<br>Procedure: Individualised minimally-invasive radio-guided parathyroidectomy<br>* Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time (minutes) | The operating time will be measured and recorded. | Duration of surgery | 
| Pathological parathyroid gland volume (ml) | The pathological parathyroid gland volume in millilitres will be measured and recorded. | Duration of surgery | 
| Pathological parathyroid gland localisation (ectopic x eutopic) | The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded. | Duration of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment