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临床试验/NCT05623787
NCT05623787进行中(未招募)不适用

Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Recurrence in Patients with High-risk Colorectal and Appendiceal Neoplasms : a Pilot Study

Laval University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
4
主要终点
Peritoneal findings

研究概览

简要总结

Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases PM. It has been demonstrated to be superior to CT for patients with known peritoneal disease from colorectal and gynaecological malignancies as a staging tool for cytoreductive surgery. It was also demonstrated to be superior for the detection of PM for gastric cancer patients otherwise considered with a resectable tumor. However, the literature is scarce on the role of DWI/MRI in the detection of peritoneal recurrence for patients with high-risk features, either colorectal cancer (CRC) or appendiceal neoplasms (AN).

The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT and diagnostic laparoscopy for detection of PM in the follow-up of patients presenting with CRC or AN and high-risk features for peritoneal recurrence and evaluate how it correlates with intraoperative findings.

详细描述

This is a multicentric, prospective study (CHU de Québec and Hôpital Maisonneuve-Rosemont). Patients will be referred to one of six surgeons with a subspeciality in peritoneal surface oncology after their index surgery for CRC or AN. After thorough assessment, patients judged without residual peritoneal disease, but at high-risk for peritoneal recurrence, will be prospectively included in the study. Patients will be assessed with CT and WB-DWI/MRI twelve months after their index surgery. For WB-DWI/MRI, the standard protocol will include the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. They will receive 20 mg of intravenous hyoscine butylbromide at the beginning of the MR exam in order to reduce bowel peristalsis. Sequences will include Axial et Coronal T2WI of the abdomen and pelvis, axial DWI with b values of 0, 50 and 1000 of the abdomen and pelvis, as well as Pre and post gadolinium-based contrast Axial and Coronal 3D T1WGRE. All patients included in the study will then undergo diagnostic laparoscopy, to provide correlation with imaging findings. Patients with no evidence of peritoneal recurrence on CT, WB-DWI/MRI and diagnostic laparoscopy will continue to be followed with serial CT and blood tumor markers (CEA, CA 19-9) as done on a routine basis. Patients with confirmed peritoneal disease at diagnostic laparoscopy will be further evaluated for cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy. The study duration will be two years for all participants.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of colorectal cancer or high-risk appendiceal neoplasm (High grade Appendiceal Mucinous Neoplasm (HAMN), goblet-cell carcinoma or adenocarcinoma).
  • No evidence of residual peritoneal disease based on referring surgeon operating report and preoperative imaging.
  • At least one high-risk feature for peritoneal recurrence, including:
  • Synchronous peritoneal metastases resected at index surgery;
  • Synchronous ovarian metastases resected at index surgery;
  • Perforated primary tumor.
  • No evidence of distant metastases.
  • Patient fit for cytoreductive surgery, if required (ECOG 0 or 1).

排除标准

  • Unresected synchronous peritoneal metastases at referral.
  • Low grade Appendiceal Mucinous Neoplasm (LAMN).
  • No high-risk feature for peritoneal recurrence.
  • Evidence of distant metastases on preoperative imaging.
  • Patient who is unable to have MRI.
  • Patient unfit for cytoreductive surgery, if required (ECOG 2 or more).

结局指标

主要结局

Peritoneal findings

时间窗: 24 months

The number of cases in which peritoneal findings on MRI matched with surgical exploration.

Early peritoneal recurrence

时间窗: 36 months

The number of cases with early peritoneal recurrence after MRI.

次要结局

  • Early distant recurrence(36 months)

研究者

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

Alexandre Brind'Amour

Doctor

Laval University

研究点 (4)

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