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

Primary Purpose

Primary Hyperparathyroidism, Thyroid Disease, Parathyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Conventional (dual-phase) SPECT/CT
Multi-phase SPECT/CT
Conventional minimally-invasive radio-guided parathyroidectomy
Individualised minimally-invasive radio-guided parathyroidectomy
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional (dual-phase) SPECT/CT

Multi-phase SPECT/CT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Operating time (minutes)
The operating time will be measured and recorded.
Pathological parathyroid gland volume (ml)
The pathological parathyroid gland volume in millilitres will be measured and recorded.
Pathological parathyroid gland localisation (ectopic x eutopic)
The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.

Full Information

First Posted
April 9, 2020
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04344886
Brief Title
Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism, Thyroid Disease, Parathyroid Diseases, Parathyroid Adenoma
Keywords
minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients are randomized into two parallel study arms.
Masking
None (Open Label)
Masking Description
No masking is being used in the study
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional (dual-phase) SPECT/CT
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-phase SPECT/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional (dual-phase) SPECT/CT
Intervention Description
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
Intervention Type
Procedure
Intervention Name(s)
Multi-phase SPECT/CT
Intervention Description
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
Intervention Type
Procedure
Intervention Name(s)
Conventional minimally-invasive radio-guided parathyroidectomy
Intervention Description
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
Intervention Type
Procedure
Intervention Name(s)
Individualised minimally-invasive radio-guided parathyroidectomy
Intervention Description
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
Primary Outcome Measure Information:
Title
Success of surgery (%)
Description
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
Title
In-vivo sensitivity (%)
Description
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
Title
In-vivo specificity (%)
Description
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
Title
In-vivo accuracy (%)
Description
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
Title
Ex-vivo sensitivity (%)
Description
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
Title
Ex-vivo specificity (%)
Description
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
Title
Ex-vivo accuracy (%)
Description
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
Secondary Outcome Measure Information:
Title
Operating time (minutes)
Description
The operating time will be measured and recorded.
Time Frame
Duration of surgery
Title
Pathological parathyroid gland volume (ml)
Description
The pathological parathyroid gland volume in millilitres will be measured and recorded.
Time Frame
Duration of surgery
Title
Pathological parathyroid gland localisation (ectopic x eutopic)
Description
The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Time Frame
Duration of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimír Dedek, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Formánek, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be made available to other researchers upon request.

Learn more about this trial

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

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