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

ConditionBone Lesion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Bone scan

    Other intervention

    the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Patients with undetermined solitary bone lesionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

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.

Time frame
24 hours
2

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.

Time frame
24 hours
3

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/ \[% of benign lesions detected with multiparametric analysis in bone scintigraphy\].

Time frame
24 hours

Other outcomes

Sponsors and contacts

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