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

Not Applicable

Recruiting

• Conditions: Bone Lesion
• Interventions: Other: Bone scan

• Registration Number: NCT05934994
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient.

Detailed Description

Bone scintigraphy includes 3 stages: study of perfusion then of early tissue uptake and finally of late bone fixation.

Hyperactivity of malignant bone lesions at the 3 stages of bone scintigraphy has been reported, but on planar scintigraphic images not allowing precise anatomical localization of the lesions.

Currently, the generalization of SPECT-CT (Single Photon Emission Computed Tomography) combined with Tomodensitometry) acquisition thanks to the deployment of semiconductor cameras, makes it possible to carry out a multiparametric analysis of bone lesions with quantification of the intensity of the signal expressed in SUVmax (Standard Uptake Value maximum) at the 3 times of the scintigraphy

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-07
• Study Start: 2023-09-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12-10
• Study Completion: 2027-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Person, having received complete information on the organization of the research and having signed the informed consent and:

  • Age ≥ 18 years old.
  • 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 +/- excision is planned.

Exclusion Criteria

• Pregnant woman or woman of childbearing age and without contraceptive means or nursing mother.
• Unstable medical condition and/or inability to remain still during recordings.
• Known allergy to one of the components of the radiopharmaceutical technetium-99m-Technescan HDP (product required to perform the bone scan).
• Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
• Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1, L. 3213-1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with undetermined solitary bone lesions	Bone scan	All patients with indeterminate solitary bone lesions undetermined on conventional imaging for whom a biopsy or excision is scheduled, will be able to participate in the study.

Primary Outcome Measures

Name	Time	Method
Assess the diagnostic performance of the Time To Peak parameter	24 hours	Sensitivity, specificity, positive predictive value and negative predictive value of the dynamic parameter Time-to-peak to characterize a benign lesion. The Time-To-Peak is defined by the time to reach the SUVmax peak, i.e. the top of the perfusion curve. The benign character is defined by criteria of biopathology at the biopsy +/- surgery.

Secondary Outcome Measures

Name	Time	Method
o evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (3 rd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.	24 hours	Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the late stage to characterize a benign lesion.
To evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (2nd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.	24 hours	Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the early time to characterize a benign lesion.
Evaluate the impact of multiparametric analysis (combination of Time-To-Peak, Standard Uptake Value max early and late) in the classification of solitary bone lesions in bone scintigraphy.	24 hours	Number of patients with a benign lesion on multiparametric bone scintigraphy analysis among patients with an indeterminate bone lesion on conventional imaging and having undergone a biopsy +/- excision, defined as: 1/ \[% of benign lesions detected with multiparametric analysis in bone scintigraphy\].

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandoeuvre les Nancy cedex, France