NUclear MEdicine DIagnostic and Artificial Intelligence (NUMEDIA)

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ClinicalTrials.gov Identifier: NCT05963841

Recruitment Status : Recruiting

First Posted : July 27, 2023

Last Update Posted : February 7, 2024

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Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Besancon

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Hyperparathyroidism	Device: treatment program

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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

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Study Type :	Observational
Estimated Enrollment :	1 participants
Observational Model:	Cohort
Time Perspective:	Other
Official Title:	Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge, Nuclear Medicine Imaging and Artificial Intelligence (AI) Tools
Actual Study Start Date :	August 1, 2023
Estimated Primary Completion Date :	August 2026
Estimated Study Completion Date :	August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

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

Other Name: diagnostic assistance program

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	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).

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963841

Contacts

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Contact: Laurent COMAS	0381218477	lcomas@chu-besancon.fr
Contact: Laurent COMAS		lcomas@chu-besancon.fr

Locations

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France
CHU Besancon	Recruiting
Besançon, France, 25030
Contact: Laurent COMAS 0381218477 lcomas@chu-besancon.fr

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

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

More Information

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Responsible Party:	Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:	NCT05963841
Other Study ID Numbers:	2023/796
First Posted:	July 27, 2023 Key Record Dates
Last Update Posted:	February 7, 2024
Last Verified:	July 2023

Keywords provided by Centre Hospitalier Universitaire de Besancon:


scintigraphy parathyroid SPECT/CT Intelligence artificial dual isotope

Additional relevant MeSH terms:

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Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases

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