Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions Whose Malignant Origin Cannot be Excluded on Conventional Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Assess the diagnostic performance of the Time To Peak parameter
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients with undetermined solitary bone lesions
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.
干预措施: Bone scan (Other)
结局指标
主要结局
Assess the diagnostic performance of the Time To Peak parameter
时间窗: 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.
次要结局
- 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.(24 hours)
- 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.(24 hours)
- 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.(24 hours)
研究者
Achraf BAHLOUL
Principal Investigator
Central Hospital, Nancy, France