NCT04344886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

4.6 years

First QC Date

April 9, 2020

Last Update Submit

December 6, 2022

Conditions

Primary HyperparathyroidismThyroid DiseaseParathyroid DiseasesParathyroid Adenoma

Keywords

minimally-invasive radio-guided parathyroidectomyin-vivoex-vivomulti-phase SPECT/CTindividualized treatment

Outcome Measures

Primary Outcomes (7)

  • Success of surgery (%)

    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.

    3 months

  • In-vivo sensitivity (%)

    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 months

  • In-vivo specificity (%)

    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 months

  • In-vivo accuracy (%)

    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 months

  • Ex-vivo sensitivity (%)

    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.

    3 months

  • Ex-vivo specificity (%)

    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.

    3 months

  • Ex-vivo accuracy (%)

    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.

    3 months

Secondary Outcomes (3)

  • Operating time (minutes)

    Duration of surgery

  • Pathological parathyroid gland volume (ml)

    Duration of surgery

  • Pathological parathyroid gland localisation (ectopic x eutopic)

    Duration of surgery

Study Arms (2)

Conventional (dual-phase) SPECT/CT

EXPERIMENTAL

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/CTProcedure: Conventional minimally-invasive radio-guided parathyroidectomy

Multi-phase SPECT/CT

EXPERIMENTAL

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/CTProcedure: Individualised minimally-invasive radio-guided parathyroidectomy

Interventions

Conventional (dual-phase) SPECT/CTPROCEDURE

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

Conventional (dual-phase) SPECT/CT
Multi-phase SPECT/CTPROCEDURE

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

Multi-phase SPECT/CT
Conventional minimally-invasive radio-guided parathyroidectomyPROCEDURE

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

Conventional (dual-phase) SPECT/CT
Individualised minimally-invasive radio-guided parathyroidectomyPROCEDURE

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

Multi-phase SPECT/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • No history of thyroid or parathyroid surgery
  • Diagnosis of primary hyperparathyroidism
  • Indication for 99mTc-MIBI SPECT/CT examination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryThyroid DiseasesParathyroid DiseasesParathyroid Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

HyperparathyroidismEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Vladimír Dedek, MD,PhD

    University Hospital Ostrava

    STUDY CHAIR

  • Martin Formánek, MD,PhD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking is being used in the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients are randomized into two parallel study arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

May 1, 2016

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will be made available to other researchers upon request.

Locations

CZ(1)