Clinical trial NCT04344886: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperparathyroidism
Thyroid Disease
Parathyroid Diseases
Parathyroid Adenoma
Keywords: minimally-invasive radio-guided parathyroidectomy
in-vivo
ex-vivo
multi-phase SPECT/CT
individualized treatment
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomized into two parallel study arms.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success of surgery (%)
timeFrame: 3 months
measure: In-vivo sensitivity (%)
timeFrame: 3 months
measure: In-vivo specificity (%)
timeFrame: 3 months
measure: In-vivo accuracy (%)
timeFrame: 3 months
measure: Ex-vivo sensitivity (%)
timeFrame: 3 months
measure: Ex-vivo specificity (%)
timeFrame: 3 months
measure: Ex-vivo accuracy (%)
timeFrame: 3 months
Secondary outcomes:
measure: Operating time (minutes)
timeFrame: Duration of surgery
measure: Pathological parathyroid gland volume (ml)
timeFrame: Duration of surgery
measure: Pathological parathyroid gland localisation (ectopic x eutopic)
timeFrame: Duration of surgery
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Vladimír Dedek, MD,PhD
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Martin Formánek, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: