- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977596
Related Studies of Imaging Features and Prognosis Between Pancreatic Neuroendocrine Tumors and Pancreatic Cancer
Grade 3 Pancreatic Neuroendocrine Tumors on MDCT: Establishing a Diagnostic Model and Comparing Survival Against Pancreatic Ductal Adenocarcinoma
- Imaging findings (including CT and MRI images) of both well-differentiated G3 PNET and poorly differentiated PNET were studied;
- The CT imaging findings of G3 stage PNET and pancreatic cancer were compared to establish a Logistic regression diagnostic model, and the survival analysis of the two was compared.
- Cox regression was used to study the risk factors for survival prognosis of well-differentiated and poorly differentiated PNET based on CT image features
Study Overview
Status
Intervention / Treatment
Detailed Description
According to the latest WHO Classification of Neuroendocrine Neoplasms (NET) in 2019, pancreatic neuroendocrine neoplasms (PNET) are divided into well-differentiated and poorly differentiated PNETs.The former is divided into G1, G2, and well differentiated G3.There are few studies on the survival outcomes of these two differentiated PNET types.The G3 imaging manifestations of the two types of differentiation have not been studied yet, and G3 PNET is often clinically misdiagnosed as pancreatic cancer, so it is necessary to differentiate the imaging manifestations and survival time of the two types.
A total of 71 patients with PNET in our hospital from January 2012 to January 2019 and 58 patients with pancreatic cancer from February 2014 to August 2015 were retrospectively collected. Complete survival time data of all patients after telephone follow-up were obtained.Since G3 PNET is very rare, the investigators enrolled 9 patients with G3 PNET in the First Affiliated Hospital of Zhejiang University School of Medicine and 7 patients with G3 PNET in the Affiliated Hospital of Air Force Military Medical University from January 2013 to October 2018.
CT images of PNET and pancreatic cancer were analyzed independently by two radiologists specializing in abdominal diagnosis, in which G3 lesions were evaluated simultaneously on MRI images and the others were evaluated only on CT images.Records clinical data and imaging characteristics: gender, age, tumor markers, tumor shape, size, tumor characteristics, edge, the expansion of the shrinking, pancreas, pancreatic pancreatitis, enhancement scan, arterial phase and portal phase lesions and the ratio of pancreatic parenchyma around, liver metastasis, peripheral vascular invasion, lymph node metastasis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis by pathology and detailed pathological information
- Enhanced CT examination or biopsy were performed within 2 months before surgery
- There was no preoperative radiotherapy or chemotherapy
Exclusion Criteria:
- No Ki-67 index
- CT value cannot be measured by ROI because of pancreatic atrophy and other reasons
- No enhanced images or missing images
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group PNETs
The investigators retrospectively analyzed data for patients who underwent contrast-enhanced MDCT for the evaluation of G3 PNETs at the Second Affiliated Hospital of Zhejiang University School of Medicine (n = 12) between January 2011 and May 2019, patients with G3 PNET who underwent MDCT at the First Affiliated Hospital of Zhejiang University School of Medicine (n = 4) and the Military Medical University of Air Force (The Fourth Military Medical University) (n = 4) between January 2013 and October 2018
|
Retrospective study without intervention
|
Group PDAC
Patients with PDAC who underwent MDCT at the Second Affiliated Hospital of Zhejiang University School of Medicine (n = 58) from February 2014 to August 2015.
|
Retrospective study without intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor size
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Maximum surface size of the lesion (cm)
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Tumor location
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Locations of the pancreas: head, neck, body and tail
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Number of lesions
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Number of lesions
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Margin
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
well-defined or ill-defined
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
tumor texture
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
solid;solid and cystic;complex cystic
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Pancreatic tail contraction
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Complicated pancreatitis
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Pancreatic duct/bile duct dilatation
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Extrapancreatic tissue invasion
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Hepatic metastasis
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Lymphatic metastasis
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
yes or no
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas plain scan
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas plain scan
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion plain scan
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion plain scan
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas artery phase
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas artery phase
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion artery phase
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion artery phase
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas portal phase
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of pancreas portal phase
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion portal phase
Time Frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
CT value of lesion portal phase
|
preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Risheng Yu, Second Affiliated Hospital of Zhejiang University School of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Pancreatic Neoplasms
- Neuroendocrine Tumors
Other Study ID Numbers
- yurisheng
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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