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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344886
• Other study ID #: FNO-ENT-Parathyroid_adenoma
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Adenoma
• Parathyroid Diseases
• Parathyroid Neoplasms
• Primary Hyperparathyroidism
• Thyroid Disease
• Thyroid Diseases

Intervention

Procedure:
• Conventional (dual-phase) SPECT/CT
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
• Multi-phase SPECT/CT
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
• Conventional minimally-invasive radio-guided parathyroidectomy
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
• Individualised minimally-invasive radio-guided parathyroidectomy
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

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