Bone scan: the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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 outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
CHRU Nancy
Vandœuvre-lès-Nancy
France
Recruiting
More Central Hospital, Nancy, France trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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