Primary HyperparathyroidismNCT04344886
Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery
A study testing Conventional (dual-phase) SPECT/CT, Multi-phase SPECT/CT and Conventional minimally-invasive radio-guided parathyroidectomy in people with Primary Hyperparathyroidism and Thyroid Disease, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Thyroid Disease, Parathyroid Diseases
- What is being tested?
- Conventional (dual-phase) SPECT/CT, Multi-phase SPECT/CT and Conventional minimally-invasive radio-guided parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- No history of thyroid or parathyroid surgery
- Diagnosis of primary hyperparathyroidism
- Indication for 99mTc-MIBI SPECT/CT examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
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
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.
Read the 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.
- Being tested
- Conventional (dual-phase) SPECT/CT, Multi-phase SPECT/CT, Conventional minimally-invasive radio-guided parathyroidectomy, Individualised minimally-invasive radio-guided parathyroidectomy
- Keywords
- minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment
- Medical subject headings
- Hyperparathyroidism, Primary, Thyroid Diseases, Parathyroid Diseases, Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional (dual-phase) SPECT/CTProcedure or surgery
Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
Multi-phase SPECT/CTProcedure or surgery
Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
Conventional minimally-invasive radio-guided parathyroidectomyProcedure or surgery
Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
Individualised minimally-invasive radio-guided parathyroidectomyProcedure or surgery
Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Conventional (dual-phase) SPECT/CT; Procedure: 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. Receives: Procedure: Multi-phase SPECT/CT; Procedure: Individualised minimally-invasive radio-guided parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
Operating time (minutes)
The operating time will be measured and recorded.
Measured: Duration of surgery
Pathological parathyroid gland volume (ml)
The pathological parathyroid gland volume in millilitres will be measured and recorded.
Measured: Duration of surgery
Pathological parathyroid gland localisation (ectopic x eutopic)
The pathological parathyroid gland localisation (ectopic x eutopic) will be recorded.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 May 2016
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients are randomized into two parallel study arms.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimír Dedek, MD,PhD, Study chair, University Hospital OstravaMartin Formánek, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344886
- Sponsor's protocol ID
- FNO-ENT-Parathyroid_adenoma
- Status last verified
- Dec 2022
- First submitted
- 9 Apr 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04344886
- Acronym / sponsor ID
- FNO-ENT-Parathyroid_adenoma
- Keywords
- minimally-invasive radio-guided parathyroidectomy, in-vivo, ex-vivo, multi-phase SPECT/CT, individualized treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients are randomized into two parallel study arms.
| Arm | Type | Receives |
|---|---|---|
| Conventional (dual-phase) SPECT/CT | Experimental | Procedure: Conventional (dual-phase) SPECT/CT, Procedure: Conventional minimally-invasive radio-guided parathyroidectomyAdult 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. |
| Multi-phase SPECT/CT | Experimental | Procedure: Multi-phase SPECT/CT, Procedure: Individualised minimally-invasive radio-guided parathyroidectomyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- No history of thyroid or parathyroid surgery
- Diagnosis of primary hyperparathyroidism
- Indication for 99mTc-MIBI SPECT/CT examination
Key exclusion criteria (6 listed)
- Minor patients
- Negative SPECT/CT findings
- Patients refusing surgery
- Previous combined surgery on the thyroid gland
- Patients in high risk of general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional (dual-phase) SPECT/CTConventional (dual-phase) SPECT/CT (after 10 and 150 minutes) | Procedure or surgery | Conventional (dual-phase) SPECT/CT |
| Multi-phase SPECT/CTMulti-phase SPECT/CT (after 10, 90, 150, 210 minutes) | Procedure or surgery | Multi-phase SPECT/CT |
| Conventional minimally-invasive radio-guided parathyroidectomyConventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration | Procedure or surgery | Conventional (dual-phase) SPECT/CT |
| Individualised minimally-invasive radio-guided parathyroidectomyIndividualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation. | Procedure or surgery | Multi-phase SPECT/CT |
Primary outcome
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.
3 secondary outcomes
Operating time (minutes)
Time frame: Duration of surgery
Pathological parathyroid gland volume (ml)
Time frame: Duration of surgery
Pathological parathyroid gland localisation (ectopic x eutopic)
Time frame: Duration of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No. Individual participant data will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimír Dedek, MD,PhD study chair
University Hospital Ostrava
Martin Formánek, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional (dual-phase) SPECT/CT, Multi-phase SPECT/CT and Conventional minimally-invasive radio-guided parathyroidectomy in people with Primary Hyperparathyroidism and Thyroid Disease, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of surgery (%) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.