跳至主要内容
临床试验/NCT06533189
NCT06533189尚未招募不适用

Developing a Whole-body Magnetic Resonance Imaging and Diffusion-weighted Imaging State-of-the-art Protocol, a Pilot Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
Radiologists' satisfaction of the quality of images

研究概览

简要总结

Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Age ≥18 years old;
  • Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;
  • Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);
  • Signed written informed consent to personal data treatment for research purposes

排除标准

  • Age <18 years old;
  • Refusal to sign the written informed consent to personal data treatment for research purposes.

结局指标

主要结局

Radiologists' satisfaction of the quality of images

时间窗: 18 months

Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items

次要结局

  • Diagnostic accuracy of the de-noised WB-MRI in detecting lesions(18 months)
  • Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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