跳至主要内容
临床试验/NCT03846882
NCT03846882Unknown不适用

The Value of PET / MRI for the Assessment of Lymph Node Metastasis and Other Prognostic Factors in Patients With Rectal Cancer

Region Västerbotten1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Improved accuracy in assessment of tumor regression following combined cytostatic and radiation treatment in rectal cancer with FDG-PET/MR compared to MRI or PET/CT?

研究概览

简要总结

The combination of FDG-PET/CT and MRI at staging of rectal cancer in diagnosis is currently very little studied. The investigator have a unique opportunity to study this. Hypothetically, with PET/MR as one hybrid imaging method, alternatively as an additional method, it could increase the accuracy of rectal cancer of moderate and high risk type, especially at primary N-staging, but also in assessing other important prognostic factors such as T-staging, peritoneal involvement, metastasis to lateral lymph nodes, EMVI and MRF involvement. The same reasoning applies to the assessment of tumor regression after CRT.

In the study, PET/MR is compared with PET/CT, diagnostic CT and MRI to evaluate the additional value of the hybrid imaging PET/MRI. The investigator also plan to evaluate how immunological, proliferative and prognostic biomarkers in blood and tumor tissue correlate with the radiological findings, and if the combination biomarker and radiology can provide additional prognostic information.

详细描述

Today, there is a variety of treatment options in diagnosed rectal cancer. The standard treatment is surgery with removal of the tumour including surrounding fat and lymph nodes in a package. Prior to surgery, the patient may be given a shorter or longer radiation treatment, the latter in combination with cytostatics, depending on staging at the time of diagnosis. Cytostatic drugs can also be given post surgery. The choice of treatment for the individual patient is based on the assessment of the imaging, ie conventional X-ray, ultrasound, computed tomography, (CT), Magnet Resonance Tomography Imaging (MRI) and Positron Emission Tomography in combination with CT (PET/CT). An accurate staging assessment is crucial for adequate treatment of rectal cancer patients to avoid over treatment, which in itself causes unnecessary suffering, or under treatment with increased risk of relapse. With today's methods, tumor size, overgrowth of other organs and spread to other organs such as liver and lung can be reasonable assessed. On the other hand, there is great uncertainty when assessing spread to lymph nodes. Better safety is also needed for other prognostically important factors such as tumor involvement of the mesorectal fasciae (MRF), i.e. the rectum surrounding the tumor, and tumor growth in venous vessels outside the intramural invasion of the intestinal wall, EMVI.

Hybrid imaging with PET combined with magnetic resonance imaging (PET/MR) is a novel method and there are currently no published studies comparing the outcome of fluoro-deoxy glucose (FDG) -PET/MR with CT, MR, PET/CT at staging of rectal cancer, both primarily and after radiation and cytostatics treatment (CRT). In this study, the investigator plan to evaluate the additional value for PET/MR in rectal cancer. Only patients to be operated are included and microscopic examination of the preparation, histopathology, will be the reference method with which survey data from the imaging methods are compared. The investigator also want to evaluate the relationship between the radiological findings and biomarkers in blood and tumor tissue to determine if there is a relationship that can provide additional prognostic information. The investigator will only include patients with intermediate and high-risk rectal cancer, as low-risk cancer is unusual with spread to lymph nodes. The study will be a prospective observation study in which all consecutive elective patients in Umeå with confirmed intermediate and high risk type rectal cancer, which give their consent, are included and examined preoperatively. Thereafter, imaging and blood and tumor tissue samples are examined and evaluated.

Primary research questions:

  • Can FDG-PET/MR provide improved accuracy in assessment of local tumor proliferation, lymph node metastasis and other important prognostic factors (MRF +, EMVI) in rectal cancer compared to currently used methods magnetic resonance imaging, (MRI), PET/CT or CT?
  • Can FDG-PET/MR provide an improved accuracy in assessment of tumor regression following combined cytostatics and radiotherapy in rectal cancer compared to MRI or PET/CT?
  • Can FDG-PET / MR in combination with blood and tumor tissue biomarkers provide additional prognostic information for intermediate and high-risk rectal cancer?

Secondary research questions:

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

入选标准

  • * verified rectal cancer of intermediate or high risk type, scheduled for surgery (non-acute surgery)

排除标准

  • kidney dysfunction
  • any other contraindications for contrast agents or examination with MRi or FDG-PET/CT

结局指标

主要结局

Improved accuracy in assessment of tumor regression following combined cytostatic and radiation treatment in rectal cancer with FDG-PET/MR compared to MRI or PET/CT?

时间窗: 8years

Sensitivity, specificity and likelihood ratios of primary and restaging FDG-PET/MR in the characterization of extramural vascular invasion and tumour deposits compared to primary and restaging FDG-PET/CT, MRI and CT alone with histopathological examination as reference standard.

Improved accuracy with FDG-PET/MR in assessment of local tumor proliferation, lymph node metastasis and other important prognostic factors (MRF +, EMVI) in rectal cancer compared to currently used methods MRI, PET/CT or CT?

时间窗: 8years

Sensitivity, specificity and likelihood ratios of primary and restaging FDG-PET/MR in the identification of mesorectal lymph node metastases compared to primary and restaging FDG-PET/CT, MRI and CT alone with histopathological examination as reference standard.

Can FDG-PET / MR in combination with blood and tumor tissue biomarkers provide additional prognostic information for intermediate and high-risk rectal cancer?

时间窗: 8years

Correlation between metabolic tumor regression grading with restaging FDG-PET/MR performed after neoadjuvant chemoradiation compared to restaging FDG-PET/CT, MRI and CT alone with histopathological tumour regression grading according to TNM as reference standard.

次要结局

  • How does the accumulation of FDG change in rectal cancer tissue when examined after 60 minutes vs examination after 90 minutes?(3years)

研究者

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

Katrine Riklund, MD; PhD

Clinical Professor, Consultant, Principal Investigator

Region Västerbotten

研究点 (1)

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