Parathyroid Gland DiseaseNCT05540795
Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT
An observational study of Parathyroid Gland Disease and Secondary Hyperparathyroidism, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Parathyroid Gland Disease, Secondary Hyperparathyroidism
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 20 Jul 2023
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe SHPT who were receiving maintenance hemodialysis and had undergone parathyroidectomy were enrolled in the study.
Who may be able to join
- 1) undergoing total parathyroidectomy with severe SHPT, and 2) undergoing 4DCT and routine unenhanced MRI.
Who cannot join
- Patients were excluded if they had known contraindications to MR or CT imaging. Patients were also excluded if their images could not be used for diagnosis due to quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of 3T Unenhanced MR Imaging for the Detection of Parathyroid Lesions Before Surgery in Hemodialysis Patients With Secondary Hyperparathyroidism Comparison With 4DCT
Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis.
Read the detailed description
MR examinations were performed by using the 3 Tesla unit (Siemens Magnetom Verio, Siemens Medical Solutions) with a dedicated eight-channel neurovascular phased array coil. The field of view was adjusted to include the area from the angle of the mandible to the level of the tracheal carina. The protocol included an axial and a coronal T1-weighted fast spin-echo (FSE) sequence, an axial T2-weighted FSE sequence with Dixon fat saturation, and a coronal and sagittal T2-weighted FSE sequence with inversion recovery fat saturation.
4DCT images were scanned with the 128-section dual-source multi-detector row unit (Somatom Definition Flash; Siemens Medical Solutions). All patients were scanned from the angle of the mandible to the carina. The 4DCT protocol included the acquisition of unenhanced images followed by the acquisition of arterial and delayed (venous) phase image series. Unenhanced images were obtained by using the following parameters: a collimation of 64×0.6 mm, 120 kVp for the deliverance of a dose-modulated amperage of 250 mAs, a pitch of 0.7, and a gantry rotation time of 0.28 seconds. The arterial and venous phase scans was performed in dual-energy mode with a dual source of 80 kVp and 140 kVp tube voltages using the following parameters: tube current-time product 230 and 89 mAs, respectively; collimation, 64 × 0.6 mm; rotation speed, 0.28 seconds; and helical pitch, 0.7. The arterial and venous phase scanning began automatically at 10 s and 35 s after the left common carotid artery reached the trigger attenuation threshold (100 HU) using automated scan-triggering software (CARE Bolus CT; Siemens Healthineers). The volume of iodinated contrast material (iohexol, Omnipaque 300; GE Healthcare, SH, China) was 70 mL, and the injection rate was 3 mL/s. The mean dual-source CT dose index volume was 34.5 mGy.
The sensitivity and specificity as well as the positive-predictive and negative-predictive values (PPV, NPV) of each imaging modality for preoperative parathyroid hyperplasia localization to the correct quadrant were compared. For the per-quadrant localization, if a lesion was suspected to be parathyroid hyperplasia by the imaging report and was correlated with the surgical and pathology results, this was interpreted as a true-positive lesion. Otherwise, if the lesion was not confirmed to be parathyroid hyperplasia during surgery, this was considered to be a false-positive case. If a lesion was not reported by the radiologist in the exact quadrant but was present during surgery and histopathologic examination, this was regarded as a false-negative lesion.
- Medical subject headings
- Parathyroid Diseases, Hyperparathyroidism, Secondary
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
The number of positive tests as a percentage of the total number of cases
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start6 Feb 2023
- Primary completion28 May 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid Gland DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Wang, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ying Wang, MD, Principal investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540795
- Sponsor's protocol ID
- ZDWY.HYXK.006
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of 3T Unenhanced MR Imaging for the Detection of Parathyroid Lesions Before Surgery in Hemodialysis Patients With Secondary Hyperparathyroidism Comparison With 4DCT
- ClinicalTrials.gov ID
- NCT05540795
- Acronym / sponsor ID
- ZDWY.HYXK.006
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 15 Sep 2022 (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.
Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis.
Detailed description
MR examinations were performed by using the 3 Tesla unit (Siemens Magnetom Verio, Siemens Medical Solutions) with a dedicated eight-channel neurovascular phased array coil. The field of view was adjusted to include the area from the angle of the mandible to the level of the tracheal carina. The protocol included an axial and a coronal T1-weighted fast spin-echo (FSE) sequence, an axial T2-weighted FSE sequence with Dixon fat saturation, and a coronal and sagittal T2-weighted FSE sequence with inversion recovery fat saturation.
4DCT images were scanned with the 128-section dual-source multi-detector row unit (Somatom Definition Flash; Siemens Medical Solutions). All patients were scanned from the angle of the mandible to the carina. The 4DCT protocol included the acquisition of unenhanced images followed by the acquisition of arterial and delayed (venous) phase image series. Unenhanced images were obtained by using the following parameters: a collimation of 64×0.6 mm, 120 kVp for the deliverance of a dose-modulated amperage of 250 mAs, a pitch of 0.7, and a gantry rotation time of 0.28 seconds. The arterial and venous phase scans was performed in dual-energy mode with a dual source of 80 kVp and 140 kVp tube voltages using the following parameters: tube current-time product 230 and 89 mAs, respectively; collimation, 64 × 0.6 mm; rotation speed, 0.28 seconds; and helical pitch, 0.7. The arterial and venous phase scanning began automatically at 10 s and 35 s after the left common carotid artery reached the trigger attenuation threshold (100 HU) using automated scan-triggering software (CARE Bolus CT; Siemens Healthineers). The volume of iodinated contrast material (iohexol, Omnipaque 300; GE Healthcare, SH, China) was 70 mL, and the injection rate was 3 mL/s. The mean dual-source CT dose index volume was 34.5 mGy.
The sensitivity and specificity as well as the positive-predictive and negative-predictive values (PPV, NPV) of each imaging modality for preoperative parathyroid hyperplasia localization to the correct quadrant were compared. For the per-quadrant localization, if a lesion was suspected to be parathyroid hyperplasia by the imaging report and was correlated with the surgical and pathology results, this was interpreted as a true-positive lesion. Otherwise, if the lesion was not confirmed to be parathyroid hyperplasia during surgery, this was considered to be a false-positive case. If a lesion was not reported by the radiologist in the exact quadrant but was present during surgery and histopathologic examination, this was regarded as a false-negative lesion.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe SHPT who were receiving maintenance hemodialysis and had undergone parathyroidectomy were enrolled in the study.
Key inclusion criteria (1 listed)
- 1) undergoing total parathyroidectomy with severe SHPT, and 2) undergoing 4DCT and routine unenhanced MRI.
Key exclusion criteria (1 listed)
- Patients were excluded if they had known contraindications to MR or CT imaging. Patients were also excluded if their images could not be used for diagnosis due to quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity
Time frame: 1month
The number of positive tests as a percentage of the total number of cases
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 13 Sep 2023.
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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.
Ying Wang, MD principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroid Gland Disease and Secondary Hyperparathyroidism, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 1 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 13 Sep 2023. 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 China. 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?
sensitivity (time frame: 1month). 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 13 Sep 2023.