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RecruitingNCT05963841NUMEDIAUpdated Feb 7, 2024

NUclear MEdicine DIagnostic and Artificial Intelligence

An observational study in Hyperparathyroidism, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hyperparathyroidism

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Keywords

  • scintigraphy
  • parathyroid
  • SPECT/CT
  • Intelligence artificial
  • dual isotope
03

In context

Hyperparathyroidism

110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.

This study's planned enrollment of 1 is below the median of 99 across 37 observational studies indexed under Hyperparathyroidism.

Browse Hyperparathyroidism studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion 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)
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1 participant (estimated)
Patient registry
No

Interventions

  • Devicetreatment program

    the study aims to set up an artificial intelligence diagnostic assistance program

    Also known as: diagnostic assistance program

06

What researchers measure

Primary outcomes

  1. Development of an artificial intelligence diagnostic program

    Development of an artificial intelligence diagnostic program

    Time frame: 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.

    Time frame: through study completion, an average of 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Aug 2026, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2023
First posted
Jul 27, 2023
StartActual
Aug 1, 2023
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2027
Last update
Feb 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05963841
Collaborators
Franche-Comté Electronique Mécanique Thermique et Optique - Sciences et Technologies, UMR 6174
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Aug 1, 2023
Primary completion
Aug 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Feb 7, 2024

Study contacts

Laurent COMAS
Contact
lcomas@chu-besancon.fr
0381218477
Laurent COMAS
Contact
lcomas@chu-besancon.fr
View the source record on ClinicalTrials.gov ↗

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