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

NCT ID: NCT04344886

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Primary Hyperparathyroidism Thyroid Disease Parathyroid Diseases Parathyroid Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients are randomized into two parallel study arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking is being used in the study

Study Groups

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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.

Group Type EXPERIMENTAL

Conventional (dual-phase) SPECT/CT

Intervention Type PROCEDURE

Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)

Conventional minimally-invasive radio-guided parathyroidectomy

Intervention Type PROCEDURE

Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration

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.

Group Type EXPERIMENTAL

Multi-phase SPECT/CT

Intervention Type PROCEDURE

Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)

Individualised minimally-invasive radio-guided parathyroidectomy

Intervention Type PROCEDURE

Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.

Interventions

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Conventional (dual-phase) SPECT/CT

Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)

Intervention Type PROCEDURE

Multi-phase SPECT/CT

Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)

Intervention Type PROCEDURE

Conventional minimally-invasive radio-guided parathyroidectomy

Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimír Dedek, MD,PhD

Role: STUDY_CHAIR

University Hospital Ostrava

Martin Formánek, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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FNO-ENT-Parathyroid_adenoma

Identifier Type: -

Identifier Source: org_study_id

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