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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Bone Lesion

Treatments: Other: Bone scan

Study type: Interventional

Funder types: Other

Identifiers

NCT05934994

2022PI051

Details and patient eligibility

About

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.

Full 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

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Patients with undetermined solitary bone lesions

Experimental group

Description:

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.

Treatment:

Other: Bone scan