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临床试验/NCT03628274
NCT03628274Unknown不适用

Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
A subjective score of suspicion of the image defined by the Lickert scale

研究概览

简要总结

Sarcomas are aggressive malignant tumors issued from mesenchymatous cells. Their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. Surgical margins remain a major prognosis factor and are directly linked to recurrence risk. Curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative Magnetic resonance imaging(MRI). Resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. Resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. Such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. A new MRI offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional MRI, which might explain some of the observed recurrences. Ultra-high field MRI, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. This is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery.

It will be propose in this project to determine the contribution of ultra-high field MRI in Soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 Tesla imaging over routine MRI through usual data comparison in 20 patients between 1,5Tesla and 7 Tesla MRI.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patients
  • All patients with soft-tissue sarcoma
  • Patients agreeing to participate in the study and having signed a consent

排除标准

  • Patients with a contraindication to MRI will be excluded: Claustrophobia, metallic foreign bodies, cardiac pacemakers, implantable chamber. There is no known additional risk for 7Tesla MRI scanning. The same contraindications as those of conventional MRI prevail.
  • Patients with bone-component sarcomas will be excluded in order to have a homogeneous group of tumors localized only in the soft tissues (and simpler analysis in high-field MRI because of the risk of artifacts related to bone).
  • Intermediate malignancies will be excluded for the same reasons.

研究组 & 干预措施

Magnetic Resonance Imaging (RMI) 7 Tesla

Experimental

干预措施: Magnetic Resonance Imaging (MRI) 7 Tesla (Device)

Magnetic Resonance Imaging (RMI) 7 Tesla

Experimental

干预措施: Magnetic Resonance Imaging (MRI) 1,5 Tesla (Device)

结局指标

主要结局

A subjective score of suspicion of the image defined by the Lickert scale

时间窗: 24 months

the invaded anatomical structures are evaluated by observation of images matched at the Lickert scale. It's based on a five stage Likert scale (0: formally benign, 1: probably benign, 2: undetermined, 3: probably malignant, 4: formally malignant).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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