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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05934994

Collaborator

(none)

Enrollment

Arm

42.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Lesion	Other: Bone scan	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

People with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduledPeople with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduled

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 10, 2023

Anticipated Primary Completion Date :

Jan 10, 2025

Anticipated Study Completion Date :

Jan 10, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Achraf BAHLOUL, Principal Investigator, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05934994

Other Study ID Numbers:

2022PI051

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 7, 2023