Clinical trial NCT05934994: Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Lesion
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: People with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduled
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Assess the diagnostic performance of the Time To Peak parameter
timeFrame: 24 hours
Secondary outcomes:
measure: 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.
timeFrame: 24 hours
measure: 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.
timeFrame: 24 hours
measure: 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.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU Nancy
Study officials:
References: