About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Bone scan
Other interventionthe bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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/ \[% of benign lesions detected with multiparametric analysis in bone scintigraphy\].
Sponsors and contacts
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