SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs

March 28, 2024 updated by: Peking Union Medical College Hospital

Somatostatin Receptor Antagonist PET/CT for Pre-operative N Stage Evaluation in Patients With Gastro-entero-pancreatic Neuroendocrine Tumors

The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with GEP-NEN undergoing surgical treatment at Peking Union Medical College Hospital.

Description

Inclusion Criteria:

  1. Age > 18 years old;
  2. Patients diagnosed with GEP-NEN by surgical pathology;
  3. Complete medical records including basic information and treatment process;
  4. Patients who have undergone preoperative contrast-enhanced CT and 68Ga-SSTR-PET/CT, and have consented to the 68Ga-SSTR-PET/CT project in the Nuclear Medicine Department.

Exclusion Criteria:

  1. Presence of concomitant malignancies;
  2. Cases diagnosed pathologically as non-GEP-NEN.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymph node metastasis status
Time Frame: 2024.04.01~2030.03.01
lymph node metastasis status confirmed by histopathology
2024.04.01~2030.03.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5098

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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