NCT06344832

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
43mo left

Started Apr 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2024Mar 2030

First Submitted

Initial submission to the registry

March 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

3.9 years

First QC Date

March 28, 2024

Last Update Submit

March 28, 2024

Conditions

Gastro-entero-pancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

  • lymph node metastasis status

    lymph node metastasis status confirmed by histopathology

    2024.04.01~2030.03.01

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age \> 18 years old;
  • Patients diagnosed with GEP-NEN by surgical pathology;
  • Complete medical records including basic information and treatment process;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2030

Last Updated

April 3, 2024

Record last verified: 2024-03