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临床试验/NCT04157166
NCT04157166已完成不适用

Evaluation of an Accelerated Body-whole Bone CT Procedure With the CZT(Cadmium-Zinc-Telluride) "VERITON-CT ™" Camera: a Comparison With the Conventional Full-body 2D Recording Procedure With or Without Complementary Tomoscintigraphy.

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
2
主要终点
concordance between the two procedures

研究概览

简要总结

The purpose of the OSS study is to evaluate a procedure involving a single full body SPECT/CT (Single photon emission computed tomography coupled with a computerized tomography) 3D recording with a new semiconductor camera,his name is VERITON-CT ™ (Spectrum Dynamics Medical). This recording can be done in less than 25 minutes due to an original system of CZT (Cadmium-Zinc-Telluride) detectors allowing to increase the quality of the images and especially, to multiply by a factor 2 to 3 the detection sensitivity. This camera is also equipped with a scanner capable of obtaining a body-to-integer recording with a low level of irradiation (≤ 2 mSv)

详细描述

Interventional study (RIPH-2), monocentric and randomized in open. All patients routinely referred for bone scans as part of a search for primary or metastatic neoplastic bone lesions (known neoplastic history) will be offered to participate in the study by the doctors of the nuclear medicine department of the University Regional Hospital Center (CHRU) from Nancy.

The capture of tracers used for bone scintigraphy (technetium-99m-labeled bisphosphonates) is highly dependent on bone remodeling, osteoblast activity and tissue perfusion . This is why bone scintigraphy is a sensitive examination, capable of detecting anomalies before their radiological translation . 3-dimensional (3D) recordings called SPECT detect bone metastases with a sensitivity equivalent to that of MRI .

These SPECT are most often produced by hybrid systems, in combination with X-ray scanner (CT) recordings, which makes it possible to correct certain imperfections in the quantification of the measured activities (attenuation, diffusion, partial volume) and also, to complete the characterization of lesions.

Bone diseases, which are often diffuse, frequently require two-dimensional (2D) whole body recordings, but these are unfortunately less informative and less sensitive than 3D recordings. This is why complementary focused SPECT / CT images are recommended for areas that are difficult to explore, especially the pelvis and spine, and when neoplastic lesions are suspected. This registration procedure is long (about 40 minutes), difficult for some patients to support, and does not offer an optimal 3D analysis of the entire skeleton.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient having read and understood the information document and having signed the consent.
  • •Patient referred for bone scintigraphy to detect possible metastatic or primary neoplastic lesions (known neoplastic antecedent), or for assessment and / or follow-up of known neoplastic bone lesions
  • •Patient agreeing to perform the additional 25 minutes of recording with the VERITON-CT ™ camera.
  • •Patient being affiliated to a social security scheme

排除标准

  • •A woman who is pregnant or of childbearing age and without suitable contraceptive means
  • •No signature of the informed consent form by the patient.
  • •Unstable medical condition and / or inability to remain still in the supine position during the recordings
  • •Person with a known allergy to one of the components of the radiotracer (TECHNESCAN HDP).
  • •Person deprived of liberty by a judicial or administrative decision.
  • •Major person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
  • •Major person unable to express consent.

研究组 & 干预措施

group 1 in pair week

Experimental

In pair week, patients will be included in group1:a conventional recording with SPECT/CT will be realized in first time

干预措施: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger (Diagnostic Test)

group 2 in odd week

Experimental

In odd week, patients will be included in group2: a 25 minutes recording 3D in camera VERITON-CT ™ will be realized in first time

干预措施: Group 1 to record a 25 minutes whole body 3D in camera VERITON-CT ™ after scintigraphy + SPECT/CT in camera d'Anger (Diagnostic Test)

结局指标

主要结局

concordance between the two procedures

时间窗: half hour

Concordance between the 2 procedures of the importance of scintigraphic abnormalities evoking a neoplastic process and which will be classified into 3 categories (these categories may correspond to different medical and therapeutic care) : 1) absence of any suspicious focus, 2) 1 or 2 metastases 3) more than 2 metastases

次要结局

  • concordance between the two procedures 3D(half hour)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathieu PERRIN

Prinicipal Investigator

Central Hospital, Nancy, France

研究点 (2)

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