Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE May 1, 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Operating time (minutes) [ Time Frame: Duration of surgery ]
    The operating time will be measured and recorded.
  • Pathological parathyroid gland volume (ml) [ Time Frame: Duration of surgery ]
    The pathological parathyroid gland volume in millilitres will be measured and recorded.
  • Pathological parathyroid gland localisation (ectopic x eutopic) [ Time Frame: Duration of surgery ]
    The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Primary Hyperparathyroidism
  • Thyroid Disease
  • Parathyroid Diseases
  • Parathyroid Adenoma
Intervention  ICMJE
  • Procedure: Conventional (dual-phase) SPECT/CT
    Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
  • Procedure: Multi-phase SPECT/CT
    Multi-phase SPECT/CT (after 10, 90, 150, 210 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
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Conventional (dual-phase) SPECT/CT
    • Procedure: Conventional minimally-invasive radio-guided parathyroidectomy
  • 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.
    Interventions:
    • Procedure: Multi-phase SPECT/CT
    • Procedure: Individualised minimally-invasive radio-guided parathyroidectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petr Vávra, Ass.Prof.,MD,PhD 0042059737 ext 2510 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344886
Other Study ID Numbers  ICMJE FNO-ENT-Parathyroid_adenoma
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will be made available to other researchers upon request.
Responsible Party University Hospital Ostrava
Study Sponsor  ICMJE University Hospital Ostrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Vladimír Dedek, MD,PhD University Hospital Ostrava
Principal Investigator: Martin Formánek, MD,PhD University Hospital Ostrava
PRS Account University Hospital Ostrava
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP