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临床试验/NCT03433287
NCT03433287Unknown不适用

Chronic Recurrent Multifocal Osteomyelitis - Search for a Bacterial Cause and Improving Imaging With PET/MRI

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Number of detected CRMO lesions

研究概览

简要总结

Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Using existing knowledge of chronic infections combined with sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or disproving bacteria as the underlying etiology.

In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.

详细描述

Epidemiology, clinical manifestations and prognosis Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. The disease occurs primarily in children and adolescents. The estimated prevalence is 1-5/10.000 in the European population, but since there are no studies providing precise estimates, the number of cases can be both under- and overestimated.

The mean age of CRMO onset is 10 years. There is a female preponderance with twice as many girls affected.

CRMO presents with bone pain with or without swelling and warmth. Some patients have a more acute presentation with severe pain, malaise and fever. All bones except the neurocranium can be affected. Involvement of the clavicle is classical, but the metaphyses of the long bones, the mandible and the pelvis are also frequently affected. Vertebral involvement is seen in 4 to 30% of cases in retrospective studies.

Extra-skeletal involvement can include the skin, the eyes and the gastrointestinal tract. Involvement of the skin may manifest as plantar pustulosis, psoriasis acne, pyoderma gangrenosum and Sweet Syndrome. In the gastrointestinal tract, Crohn's disease or lesions mimicking this disease have been associated with CRMO.

Previously, the prognosis of CRMO patients was considered favorable, as the disease is often self-limiting, but newer studies have revealed that physical impairment may persist in up to 50% of patients. They typically suffer from chronic pain, bone deformities and have increased fracture risk. Furthermore, there is evidence that CRMO may evolve into spondyloarthropathy with clinical and radiological sacroiliitis.

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • CRMO diagnosis verified by biopsy
  • Age under 18 years at diagnosis
  • Malignant disease excluded
  • Informed written consent

排除标准

  • Bone biopsy not performed
  • Patients not eligible for MRI (metallic foreign objects, severe claustrophobia)
  • Pregnancy

结局指标

主要结局

Number of detected CRMO lesions

时间窗: 1 hour after PET/MRI scan

Compare no. of detected CRMO lesions on PET/MRI and standard diagnostic tests

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Øbro Fosbøl

Medical doctor

Rigshospitalet, Denmark

研究点 (2)

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