Primary HyperparathyroidismECHOPARATNCT03605472
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
A study testing cervical ultrasound in people with Primary Hyperparathyroidism, run by CHU de Reims at 1 site in France.
Trial summary
The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH). This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- cervical ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2017to 5 Mar 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
- Patients with primary hyperparathyroidism with surgery indication
- Age > 18yo
Who cannot join
- surgical contraindication
- medical treatment by cinacalcet
- non sporadic hyperparathyroidism
- Age <18yo
- Protected by the law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Brigitte DELEMER, 0326788101 ext. 0033, bdelemer@chu-reims.fr
About this study
The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).
This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.
Read more
The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).
However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- cervical ultrasound
- Keywords
- primary hyperparathyroidism, cervical ultrasound, echoscintigraphy
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical ultrasoundOther
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: cervical ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma parathyroid diagnosed using cervical ultrasound
Adenoma parathyroid diagnosed using cervical ultrasound. Cervical ultrasound will be realized by a endocrinologist trained in the cervical ultrasound and not informed of the results of the echoscintigraphy
Measured: Day 0
Adenoma parathyroid diagnosed using echoscintigraphy
Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound
Measured: Day 0
Adenoma parathyroid diagnosed using anatomopathology
Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start5 Oct 2017
- Primary completion5 Oct 2019 (estimated)
- Study completion5 Mar 2020 (estimated)
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.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605472
- Sponsor's protocol ID
- PA17094
- Acronym
- ECHOPARAT
- Status last verified
- Jul 2018
- First submitted
- 20 Jul 2018
- Last updated
- 30 Jul 2018
- 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 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03605472
- Acronym / sponsor ID
- ECHOPARAT / PA17094
- Conditions
- Primary Hyperparathyroidism
- Keywords
- primary hyperparathyroidism, cervical ultrasound, echoscintigraphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 5 Oct 2019 (estimated)
- Study completion
- 5 Mar 2020 (estimated)
- First posted
- 30 Jul 2018 (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 biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).
This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.
The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).
However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: cervical ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary hyperparathyroidism with surgery indication
- Age > 18yo
Key exclusion criteria (5 listed)
- surgical contraindication
- medical treatment by cinacalcet
- non sporadic hyperparathyroidism
- Age <18yo
- Protected by the law
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 |
|---|---|---|
| cervical ultrasoundcervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound | Other | Patients |
Primary outcome
Adenoma parathyroid diagnosed using cervical ultrasound
Time frame: Day 0
Adenoma parathyroid diagnosed using cervical ultrasound. Cervical ultrasound will be realized by a endocrinologist trained in the cervical ultrasound and not informed of the results of the echoscintigraphy
Adenoma parathyroid diagnosed using echoscintigraphy
Time frame: Day 0
Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound
Adenoma parathyroid diagnosed using anatomopathology
Time frame: Day 0
Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Related trials for Primary Hyperparathyroidism
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Not yet recruiting
Treating PHPT With the nPulse™ Vybrance™ PE System
Primary Hyperparathyroidism
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical ultrasound in people with Primary Hyperparathyroidism, run by CHU de Reims at 1 site in France.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Jul 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte DELEMER (0326788101, bdelemer@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma parathyroid diagnosed using cervical ultrasound (time frame: Day 0). The study lists 3 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 30 Jul 2018.