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

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ClinicalTrials.gov Identifier: NCT04344886
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Thyroid Disease Parathyroid Diseases Parathyroid Adenoma Procedure: Conventional (dual-phase) SPECT/CT Procedure: Multi-phase SPECT/CT Procedure: Conventional minimally-invasive radio-guided parathyroidectomy Procedure: Individualised minimally-invasive radio-guided parathyroidectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344886


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,PhD 0042059737 ext 2510 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70852
Contact: Petr Vávra, Ass.Prof.,MD,PhD    0042059737 ext 2510    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Vladimír Dedek, MD,PhD         
Sub-Investigator: Martin Formánek, MD,PhD         
Sub-Investigator: Michal Koláček, Ing.         
Sub-Investigator: Martin Havel, MD,PhD         
Sub-Investigator: Pavel Komínek, prof.,MD,PhD         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Study Chair: Vladimír Dedek, MD,PhD University Hospital Ostrava
Principal Investigator: Martin Formánek, MD,PhD University Hospital Ostrava
More Information
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT04344886    
Other Study ID Numbers: FNO-ENT-Parathyroid_adenoma
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be made available to other researchers upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
minimally-invasive radio-guided parathyroidectomy
in-vivo
ex-vivo
multi-phase SPECT/CT
individualized treatment
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Thyroid Diseases
Parathyroid Diseases
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms