Whole Body MRI in Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- To evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
研究概览
简要总结
Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.
详细描述
Whole Body-Magnetic Resonance Imaging (WB-MRI) is a radiation-free and, usually, contrast administration-free imaging method for detecting bone and soft tissue pathology. It's part of the "next generation imaging techniques" combining high quality morphological images with "functional" information on diffusivity of water molecules through diffusion- weighted sequences (DWI).
Nowadays WB-MRI has been introduced in several guidelines in oncological settings, in particular for staging and relapse in patients affected by monoclonal plasma cell disorders, screening in patients with cancer predisposition syndromes (Li fraumeni syndrome, hereditary paraganglioma / pheochromocytoma syndrome, neurofibromatosis) and staging and follow-up of cancer patients affected by predominant bone metastatic pattern, particularly advanced prostate cancer and breast cancer.
The current limit on the diffusion of the technique is that it is not widely available as it requires an optimal set up of both the machine with specific sequences and the acquisition protocol, as well as dedicated, trained staff.
DWI is emerging as a core sequence of WB-MRI protocols for disease assessment because of its sensitiveness to tissue cellularity and cell viability offering excellent lesion-to-background contrast and quantification of the degree of water motion by calculation of the apparent diffusion coefficient (ADC); changes in ADC can reflect variations in cellularity. Fat-Fraction (FF) is another emerging sequence for tissue characterization that quantifies the relative amount of fat. A better investigation of these novel sequences can maximize sensitivity and specificity in order to improve our understanding of diseases assessment.
The aim of this observational study is to evaluate whether WB-MRI allows an improvement in identification of site of tumour disease or earlier progression in comparison to other methodologies that are nowadays the standard of care due to their widespread availability in hospitals and quicker execution, particularly Bone Scintigraphy (BS) Computed Tomography (CT), Positron Emission Tomography/Computed Tomography (PET/CT) .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above.
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged ≥ 18 years.
- •Life expectancy greater than 3 months.
排除标准
- •Patients with MRI-unsafe prostheses and devices.
- •Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.
结局指标
主要结局
To evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
时间窗: 36 months
To evaluate the accuracy of WB-MRI in terms of: -Lymphoma:diameters of lesions will be assessed.
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to other standard methodologies and to assess different patterns of response, stable disease, and progression that can be observed on WB-MRI.
时间窗: 36 months
Pattern of response/progression will be determined in terms of: -Lymphoma:for the diameter evaluation of max 5 lymphnodes or lesion integrated with apparent diffusion coefficient (ADC) evaluation will be applied on WB-MRI.
To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients.
时间窗: 36 months
The number of times a patient treatment's course was changed by clinicians after evidences provided by WB-MRI investigations as per clinical routine.
次要结局
- Identification of imaging biomarkers for precise disease differentiation or for response prediction.(36 months)