Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963841
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-07-13
Brief Title:
NUclear MEdicine DIagnostic and Artificial Intelligence
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Contribution to Disease Diagnosis and Prognosis Based on the Fusion of Expert Knowledge Nuclear Medicine Imaging and Artificial Intelligence AI Tools
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUMEDIA
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 SPECTCT - positron emission tomography PET Choline
Secondary endpoints Concordance between diagnoses made by nuclear physicians using both methods current method and new treatment method
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 SPECTCT - 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 SPECTCT 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 patients 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 SPECTCT 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 13042022 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 SPECTCT 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
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 SPECTCT 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 patients 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 SPECTCT 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 13042022 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 SPECTCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None