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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Lesion
• Intervention / Treatment: Other: Bone scan

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique ROCH, MSc; Phone Number: +33 383154276; Email: v.roch@chru-nancy.fr
• Study Contact Backup: Name: ACHRAF BAHLOUL, MD, MSc; Phone Number: +33 383154003; Email: a.bahloul@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre les Nancy cedex, France, 54511
    • Recruiting
    • CHRU Nancy
    • Contact: Véronique ROCH, MSc; Phone Number: +33 0383154276; Email: v.roch@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with undetermined solitary bone lesions; 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.	Other: Bone scan; the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation; Other Names: Bone scan in single photon emission computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the diagnostic performance of the Time To Peak parameter	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the early time to characterize a benign lesion.	24 hours
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.	Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the late stage to characterize a benign lesion.	24 hours
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.	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].	24 hours

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): January 10, 2027

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022PI051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No