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Neuroendocrine Tumor of PancreasNCT04977596

Related Studies of Imaging Features and Prognosis Between Pancreatic Neuroendocrine Tumors and Pancreatic Cancer

An observational study of Neuroendocrine Tumor of Pancreas and Carcinoma, Pancreatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. Imaging findings (including CT and MRI images) of both well-differentiated G3 PNET and poorly differentiated PNET were studied; 2. 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. 3. Read more about this study

Who is it for?
Any age
How many people
78 participants
Where
1 siteChina
Study dates
1 Jan 2012to 25 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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, and consecutive 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.

Who may be able to join

  • 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

Who cannot join

  • No Ki-67 index
  • CT value cannot be measured by ROI because of pancreatic atrophy and other reasons
  • No enhanced images or missing images

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Grade 3 Pancreatic Neuroendocrine Tumors on MDCT: Establishing a Diagnostic Model and Comparing Survival Against Pancreatic Ductal Adenocarcinoma

  1. Imaging findings (including CT and MRI images) of both well-differentiated G3 PNET and poorly differentiated PNET were studied;
  2. 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.
  3. Cox regression was used to study the risk factors for survival prognosis of well-differentiated and poorly differentiated PNET based on CT image features
Read the 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.

Being tested
No intervention
Medical subject headings
Adenoma, Islet Cell, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    Retrospective study without intervention

Study groups in NCT04977596
Study groupRoleWhat they receive
Group PNETsThe 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
Receives: Other: No intervention
Group PDACPatients with PDAC who underwent MDCT at the Second Affiliated Hospital of Zhejiang University School of Medicine (n = 58) from February 2014 to August 2015.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor size

    Maximum surface size of the lesion (cm)

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  2. Tumor location

    Locations of the pancreas: head, neck, body and tail

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  3. Number of lesions

    Number of lesions

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  4. Margin

    well-defined or ill-defined

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  5. tumor texture

    solid；solid and cystic；complex cystic

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  6. Pancreatic tail contraction

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  7. Complicated pancreatitis

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  8. Pancreatic duct/bile duct dilatation

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  9. Extrapancreatic tissue invasion

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  10. Hepatic metastasis

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  11. Lymphatic metastasis

    yes or no

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  12. CT value of pancreas plain scan

    CT value of pancreas plain scan

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  13. CT value of lesion plain scan

    CT value of lesion plain scan

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  14. CT value of pancreas artery phase

    CT value of pancreas artery phase

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  15. CT value of lesion artery phase

    CT value of lesion artery phase

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  16. CT value of pancreas portal phase

    CT value of pancreas portal phase

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

  17. CT value of lesion portal phase

    CT value of lesion portal phase

    Measured: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start1 Jan 2012
  3. Primary completion1 Jan 2019
  4. Study completion25 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04977596
Sponsor's protocol ID
yurisheng
Status last verified
Mar 2020
First submitted
12 Jul 2021
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Tumor of Pancreas and Carcinoma, Pancreatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor size (time frame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04977596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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