Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer

Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Diagnostic test: radiomics

Detailed Description

Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pancreatic tumor patients

Description

Inclusion Criteria:

• radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data

Exclusion Criteria:

• (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive lymph node metastasis; pathological diagnosis :Positive lymph node metastasis	Diagnostic test: radiomics
Negative lymph node metastasis; pathological diagnosis :Negative lymph node metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiomics features	1409 radiomics features can be extracted from the images.	After sketching the ROI

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Huishu Yuan, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M2021060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No