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NCT Number: NCT04344886

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

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperparathyroidism Hyperparathyroidism, Primary Neoplasms Neoplasms by Site Parathyroid Adenoma Parathyroid Diseases Parathyroid Neoplasms Thyroid Disease Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional (dual-phase) SPECT/CT

Procedure

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

Multi-phase SPECT/CT

Procedure

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

Conventional minimally-invasive radio-guided parathyroidectomy

Procedure

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

Individualised minimally-invasive radio-guided parathyroidectomy

Procedure

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

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Operating time (minutes)

    Time frame: Duration of surgery

    The operating time will be measured and recorded.

  2. Pathological parathyroid gland volume (ml)

    Time frame: Duration of surgery

    The pathological parathyroid gland volume in millilitres will be measured and recorded.

  3. Pathological parathyroid gland localisation (ectopic x eutopic)

    Time frame: Duration of surgery

    The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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