HyperparathyroidismNUMEDIANCT05963841
NUclear MEdicine DIagnostic and Artificial Intelligence
An observational study of Hyperparathyroidism, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Artificial intelligence algorithms for parathyroid adenoma detection in parathyroid scans The aim of the study is to develop programs for the automatic subtraction of planar and tomographic parathyroid images and for the localization of parathyroid adenomas using artificial intelligence tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- treatment program
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Men and women over 18 years of age who have undergone dual-isotope parathyroid scintigraphy (standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions).
Who may be able to join
- Men and women over 18 years of age who underwent dual-isotope parathyroid scintigraphy.
- No refusal to use data for research purposes
- Retrospective data (after 13/04/2022: Date of posting of patient information in the department) and prospective data
Who cannot join
- Patient refusal to use data for research purposes
- Patients who did not benefit from the standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laurent COMAS contact
France1 site, 1 recruiting
- Recruiting
CHU Besancon
Besançon, 25030
Laurent COMAS, 0381218477, lcomas@chu-besancon.fr
About this study
Official title: Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge, Nuclear Medicine Imaging and Artificial Intelligence (AI) Tools
Artificial intelligence algorithms for parathyroid adenoma detection in parathyroid scans The aim of the study is to develop programs for the automatic subtraction of planar and tomographic parathyroid images and for the localization of parathyroid adenomas using artificial intelligence tools.
Inclusion criteria Patients having undergone a double isotope parathyroid diagnostic examination using the standard Besançon University Hospital protocol (double injection of 123I and 99mTc, pinhole image, low energy high resolution (LEHR) and (single-photon emission tomography / Computed tomography) SPECT/CT +/- (positron emission tomography (PET) Choline).
Secondary endpoints Concordance between diagnoses made by nuclear physicians using both methods (current method and new treatment method).
Read the detailed description
State of the art :
Planar scintigraphy of the parathyroid glands offers good diagnostic performance. The introduction of SPECT coupled with CT ten years ago has improved anatomical location, facilitating surgery.
With dual-isotope scans, the physician has to subtract the images to highlight the parathyroid adenomas, and use the SPECT/CT slices to pinpoint the exact location of the adenomas.
Several software packages, supplied by nuclear medicine image processing software publishers, are available on the market, but they require numerous actions on the part of doctors, which reduce reproducibility and necessitate a learning curve for the physician.
Research Hypothesis :
The images were taken as part of the patient's diagnosis, without any additional acquisition compared with clinical routine.
Acquisitions were of good quality, with good centering of the thyroid on the images.
The 3 Pinhole, LEHR and SPECT/CT acquisitions were performed after injection of Iodine 123 and 3 hours after Technetium 99m.
Expected results :
Creation of a program for automatic subtraction of planar and tomographic images. Use artificial intelligence algorithms to help doctors with their diagnosis.
Main objective :
Development of an artificial intelligence-based diagnostic assistance program.
Secondary objectives :
Creation of an automatic program for subtracting double-isotope parathyroid images. This image processing is a prerequisite for artificial intelligence analysis methods.
Inclusion Criteria :
Men and women over 18 years of age who have undergone double-isotope parathyroid scintigraphy.
No refusal to use data for research purposes Retrospective (after 13/04/2022: Date of posting of patient information in the department) and prospective data
Non-inclusion criteria :
Patient refusal to use data for research purposes Patients who did not benefit from the standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions).
Description of research methodology :
Retrospective and prospective study using data from the medical records of patients meeting the eligibility criteria. No additional examinations were carried out on the patient.
- Conditions
- Hyperparathyroidism
- Being tested
- treatment program
- Keywords
- scintigraphy, parathyroid, SPECT/CT, Intelligence artificial, dual isotope
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment programDevice
Also called diagnostic assistance program
the study aims to set up an artificial intelligence diagnostic assistance program
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an artificial intelligence diagnostic program
Development of an artificial intelligence diagnostic program
Measured: through study completion, an average of 4 years
Secondary outcomes (1)
Development of an automatic program for subtracting double-isotope parathyroid images.
Development of an automatic program for subtracting double-isotope parathyroid images.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Franche-Comté Electronique Mécanique Thermique et Optique - Sciences et Technologies, UMR 6174
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963841
- Sponsor's protocol ID
- 2023/796
- Acronym
- NUMEDIA
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge, Nuclear Medicine Imaging and Artificial Intelligence (AI) Tools
- ClinicalTrials.gov ID
- NCT05963841
- Acronym / sponsor ID
- NUMEDIA / 2023/796
- Conditions
- Hyperparathyroidism
- Keywords
- scintigraphy, parathyroid, SPECT/CT, Intelligence artificial, dual isotope
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Franche-Comté Electronique Mécanique Thermique et Optique - Sciences et Technologies, UMR 6174
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jul 2023 (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.
Artificial intelligence algorithms for parathyroid adenoma detection in parathyroid scans The aim of the study is to develop programs for the automatic subtraction of planar and tomographic parathyroid images and for the localization of parathyroid adenomas using artificial intelligence tools.
Inclusion criteria Patients having undergone a double isotope parathyroid diagnostic examination using the standard Besançon University Hospital protocol (double injection of 123I and 99mTc, pinhole image, low energy high resolution (LEHR) and (single-photon emission tomography / Computed tomography) SPECT/CT +/- (positron emission tomography (PET) Choline).
Secondary endpoints Concordance between diagnoses made by nuclear physicians using both methods (current method and new treatment method).
Detailed description
State of the art :
Planar scintigraphy of the parathyroid glands offers good diagnostic performance. The introduction of SPECT coupled with CT ten years ago has improved anatomical location, facilitating surgery.
With dual-isotope scans, the physician has to subtract the images to highlight the parathyroid adenomas, and use the SPECT/CT slices to pinpoint the exact location of the adenomas.
Several software packages, supplied by nuclear medicine image processing software publishers, are available on the market, but they require numerous actions on the part of doctors, which reduce reproducibility and necessitate a learning curve for the physician.
Research Hypothesis :
The images were taken as part of the patient's diagnosis, without any additional acquisition compared with clinical routine.
Acquisitions were of good quality, with good centering of the thyroid on the images.
The 3 Pinhole, LEHR and SPECT/CT acquisitions were performed after injection of Iodine 123 and 3 hours after Technetium 99m.
Expected results :
Creation of a program for automatic subtraction of planar and tomographic images. Use artificial intelligence algorithms to help doctors with their diagnosis.
Main objective :
Development of an artificial intelligence-based diagnostic assistance program.
Secondary objectives :
Creation of an automatic program for subtracting double-isotope parathyroid images. This image processing is a prerequisite for artificial intelligence analysis methods.
Inclusion Criteria :
Men and women over 18 years of age who have undergone double-isotope parathyroid scintigraphy.
No refusal to use data for research purposes Retrospective (after 13/04/2022: Date of posting of patient information in the department) and prospective data
Non-inclusion criteria :
Patient refusal to use data for research purposes Patients who did not benefit from the standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions).
Description of research methodology :
Retrospective and prospective study using data from the medical records of patients meeting the eligibility criteria. No additional examinations were carried out on the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women over 18 years of age who have undergone dual-isotope parathyroid scintigraphy (standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions).
Key inclusion criteria (3 listed)
- Men and women over 18 years of age who underwent dual-isotope parathyroid scintigraphy.
- No refusal to use data for research purposes
- Retrospective data (after 13/04/2022: Date of posting of patient information in the department) and prospective data
Key exclusion criteria (2 listed)
- Patient refusal to use data for research purposes
- Patients who did not benefit from the standard acquisition protocol (123I injection followed by 99mTc 3 hours after LEHR, PINHOLE and SPECT/CT acquisitions)
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 |
|---|---|---|
| treatment programAlso: diagnostic assistance programthe study aims to set up an artificial intelligence diagnostic assistance program | Device | – |
Primary outcome
Development of an artificial intelligence diagnostic program
Time frame: through study completion, an average of 4 years
Development of an artificial intelligence diagnostic program
1 secondary outcome
Development of an automatic program for subtracting double-isotope parathyroid images.
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Laurent COMAS contact
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 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent COMAS (0381218477, lcomas@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an artificial intelligence diagnostic program (time frame: through study completion, an average of 4 years). 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 Feb 2024.