Applying PET/MR in Oncology - a Prospective Project
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/
研究概览
简要总结
Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016.
Imaging plays a pivotal role in cancer management, and multiple techniques are used in all phases of cancer management. The overall morphological, structural, metabolic and functional information obtained in imaging is used for improved individualized therapy planning. Different imaging modalities are available during different time points in the natural history of different malignancies:
Early detection of cancer through screening based on imaging is probably a major contributor to a reduction in mortality for certain cancers .
Once a diagnosis is made, determining the clinical stage of cancer, meaning the extent of the disease before any treatment is given, is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar stage . Precise clinical staging of cancer is crucial. Not only that this clear non-ambiguous description is a key factor that defines prognosis, it is also a chief component of inclusion, exclusion, and stratification criteria for clinical trials. Several cancer staging systems are used worldwide. The most clinically useful staging system is the tumor, node, and metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC). The AJCC TNM system classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M). There is a TNM staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The clinical TNM (cTNM) classification should be used to determine correctly the clinical stage of cancer and to help guide primary therapy planning.
详细描述
Stage may be defined at several time points during the monitoring period of cancer patients. When using imaging obtained during the relevant time frame, one may use one of the other TNM categories to stage correctly the cancer:
For example, imaging is of high value in assessing therapy response during and after systemic and/or radiation therapy is given . Using imaging data and the clinical posttherapy TNM classification (ycTNM) is helpful in determining the patient's response to treatment.
In case a patient is given the systemic therapy as a neoadjuvant therapy before a planned curative surgery, imaging may categorize the patient as a responder vs non-responder. If categorized as an early non-responder, another therapy or an upfront surgery may be advised, while eliminating therapy toxicity. If imaging, however, supports major response to treatment, more conservative treatment and avoidance of surgical intervention may be considered and change patients quality of life dramatically.
In patients given a systemic therapy as a curative or a palliative therapy, assessing the response via imaging is crucial as well - if imaging studies support a progressive disease, changing therapy protocol is advised. In a disease controlled by the therapy, imaging may aid in guiding follow-up schedule, lifestyle and medical management.
In the context of therapy response assessment, imaging is also important in assessing side effects of the therapy. Imaging may identify radiation-induced injuries, and may recognize pathologies associated with chemotherapy, biologic and immunotherapy.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed in One of the cancers being investigated.
- •Only in Sarcoma:20 children and adults with newly diagnosed sarcomas. Children will be included if can perform the study without sedation, and with written parental approval.
排除标准
- •Patients younger than 18 years.
- •Patients contraindication to MRI or to intravenous gadolinium injection.
结局指标
主要结局
Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/
时间窗: 1 year
次要结局
未报告次要终点