NCT05963841

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Aug 2023Aug 2027

First Submitted

Initial submission to the registry

July 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 7, 2024

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

July 13, 2023

Last Update Submit

February 6, 2024

Conditions

Keywords

scintigraphyparathyroidSPECT/CTIntelligence artificialdual isotope

Outcome Measures

Primary Outcomes (1)

  • Development of an artificial intelligence diagnostic program

    Development of an artificial intelligence diagnostic program

    through study completion, an average of 4 years

Secondary Outcomes (1)

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

    through study completion, an average of 2 years

Interventions

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

Also known as: diagnostic assistance program

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Central Study Contacts

Laurent COMAS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 27, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

February 7, 2024

Record last verified: 2023-07

Locations