Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID05934994

Contribution of Multiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions Whose Malignant Origin Cannot be Excluded on Conventional Imaging

Led by Central Hospital, Nancy, France · Updated on 2025-01-08

68

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of non-invasive Single Photon Emission Computed Tomography combined with CT (SPECT-CT) bone scintigraphy to better characterize solitary bone lesions. The study aims to determine if this imaging method can help exclude malignancy and reduce the need for biopsies and related complications. This approach builds on previous findings that malignant bone lesions show increased activity at all three stages of bone scintigraphy but lacked precise anatomical localization on planar images. The study involves a bone scan procedure with three stages: perfusion study, early tissue uptake, and late bone fixation. Participants with indeterminate solitary bone lesions scheduled for biopsy or excision will undergo the multiparametric analysis using SPECT-CT. The imaging will quantify signal intensity (SUVmax) at each stage to assess lesion nature. This analysis may improve classification of solitary bone lesions compared to conventional imaging. Participants will undergo the bone scintigraphy and have their lesions analyzed using multiple parameters, including Time To Peak and Standard Uptake Value max at early and late stages. Researchers will measure the diagnostic performance of these parameters within 24 hours. The study includes informed consent, social security affiliation, and assessments of safety and exclusion factors such as pregnancy and allergies to the radiopharmaceutical. The trial period extends until January 2027.

CONDITIONS

Brief Title

Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Person, having received complete information on the organization of the research and having signed the informed consent
  • Age 18 years or older
  • Having read and understood the information document
  • Affiliated to a social security scheme
  • Patient with an indeterminate solitary bone lesion on conventional imaging, for which an indication for biopsy or excision is planned
Not Eligible

You will not qualify if you...

  • Pregnant woman or woman of childbearing age without contraceptive means or nursing mother
  • Unstable medical condition or inability to remain still during recordings
  • Known allergy to the radiopharmaceutical technetium-99m-Technescan HDP
  • Person deprived of liberty by judicial or administrative decision
  • Person subject to psychiatric care under relevant legal articles

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo bone scintigraphy consisting of three stages: perfusion study, early tissue uptake, and late bone fixation to analyze solitary bone lesions.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

CHRU Nancy

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

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Research Team

A

ACHRAF BAHLOUL, MD, MSc

V

VERONIQUE ROCH, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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