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

December 6, 2022 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional (dual-phase) SPECT/CT
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
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
Procedure: Conventional minimally-invasive radio-guided parathyroidectomy
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
Experimental: Multi-phase SPECT/CT
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
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
Procedure: Individualised minimally-invasive radio-guided parathyroidectomy
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success of surgery (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operating time (minutes)
Time Frame: Duration of surgery
The operating time will be measured and recorded.
Duration of surgery
Pathological parathyroid gland volume (ml)
Time Frame: Duration of surgery
The pathological parathyroid gland volume in millilitres will be measured and recorded.
Duration of surgery
Pathological parathyroid gland localisation (ectopic x eutopic)
Time Frame: Duration of surgery
The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vladimír Dedek, MD,PhD, University Hospital Ostrava
  • Principal Investigator: Martin Formánek, MD,PhD, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FNO-ENT-Parathyroid_adenoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will be made available to other researchers upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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