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NCT Number: NCT05963841

NUclear MEdicine DIagnostic and Artificial Intelligence

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

treatment program

Device

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

Other names: diagnostic assistance program

Primary outcomes

  1. Development of an artificial intelligence diagnostic program

    Time frame: through study completion, an average of 4 years

    Development of an artificial intelligence diagnostic program

Secondary outcomes

  1. Development of an automatic program for subtracting double-isotope parathyroid images.

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

    Development of an automatic program for subtracting double-isotope parathyroid images.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent COMAS

CONTACT

[email protected]

0381218477

Laurent COMAS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Franche-Comté Electronique Mécanique Thermique et Optique - Sciences et Technologies, UMR 6174

Registry information

Official study title

Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge, Nuclear Medicine Imaging and Artificial Intelligence (AI) Tools

Acronym: NUMEDIA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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