Primary HyperparathyroidismPARAT-CZTNCT02854345
Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera
A study testing Tomoscintigraphic parathyroid imaging on a CZT camera in people with Primary Hyperparathyroidism, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Tomoscintigraphic parathyroid imaging on a CZT camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2014to 9 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suffering from sporadic primary hyperparathyroidism
- referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands
- who have given their written consent
- who benefit from the French Government Medical Insurance
Who cannot join
- pregnant women
- ages < 18 or > 80 years
- hyperparathyroidism recidive after a first surgery
- secondary or tertiary hyperparathyroidism
- Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism
- absence of written consent
- non-beneficiary of the French Government Medical Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera
The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.
Read the detailed description
The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Tomoscintigraphic parathyroid imaging on a CZT camera
- Keywords
- CZT camera, pinhole
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomoscintigraphic parathyroid imaging on a CZT cameraDevice
| Study group | Role | What they receive |
|---|---|---|
| Tomoscintigraphic parathyroid imaging on a CZT camera | Experimental | Tomoscintigraphic parathyroid imaging on a CZT camera Receives: Device: Tomoscintigraphic parathyroid imaging on a CZT camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start4 Sep 2014
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
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 Centre Hospitalier Universitaire de BesanconThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constantin Ungureanu, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854345
- Sponsor's protocol ID
- P/2013/212
- Acronym
- PARAT-CZT
- Status last verified
- Sep 2024
- First submitted
- 29 Jul 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera
- ClinicalTrials.gov ID
- NCT02854345
- Acronym / sponsor ID
- PARAT-CZT / P/2013/212
- Conditions
- Primary Hyperparathyroidism
- Keywords
- CZT camera, pinhole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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 goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.
Detailed description
The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomoscintigraphic parathyroid imaging on a CZT camera | Experimental | Device: Tomoscintigraphic parathyroid imaging on a CZT cameraTomoscintigraphic parathyroid imaging on a CZT camera |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- suffering from sporadic primary hyperparathyroidism
- referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands
- who have given their written consent
- who benefit from the French Government Medical Insurance
Key exclusion criteria (7 listed)
- pregnant women
- ages < 18 or > 80 years
- hyperparathyroidism recidive after a first surgery
- secondary or tertiary hyperparathyroidism
- Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism
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 |
|---|---|---|
| Tomoscintigraphic parathyroid imaging on a CZT camera | Device | Tomoscintigraphic parathyroid imaging on a CZT camera |
Primary outcome
Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery
Time frame: 6 months
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Constantin Ungureanu, MD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomoscintigraphic parathyroid imaging on a CZT camera in people with Primary Hyperparathyroidism, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 7 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 19 Sep 2024. 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?
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?
Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery (time frame: 6 months). 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 19 Sep 2024.