PET-CT Predicting Segement Specific Lymph Nodes Metastasis

October 7, 2023 updated by: Haiquan Chen, Fudan University

The Value of PET-CT in Predicting Segement Specific Lymph Nodes Metastasis in Non Small Cell Lung Cancer

This study is a multicenter prospective clinical study that aims to evaluate the predictive value of preoperative PET-CT results (such as SUV uptake, size of tumor lymph nodes, and differences in FDG uptake compared to surrounding tissues) for lymph node metastasis in patients with non-small cell lung cancer. During surgery, all patients underwent systematic mediastinal lymph node dissection. The final pathological results were used to assess the predictive value of PET-CT for segment-specific lymph node metastasis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Probability Sample

Study Population

Patients had non small cell lung cancer received surgery and systematic lymph node dissection.

Description

Inclusion Criteria:

  • Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from the primary lesion.
  • Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.
  • No enlarged mediastinal lymph nodes observed on preoperative contrast-enhanced CT.
  • Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
  • Systematic lymph node dissection performed during surgery.
  • No prior radiotherapy or chemotherapy for initial treatment.
  • No history of malignant tumors.

Exclusion Criteria:

  • Locally advanced or distant metastasis.
  • Pleural dissemination observed during surgery.
  • History of malignant tumors.
  • Received neoadjuvant therapy.
  • Systematic lymph node dissection not performed during surgery.
  • Histopathological examination reveals lung malignancies other than non-small cell lung cancer (NSCLC).

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
Time Frame
Predictive value of PET-CT for segment-specific lymph node metastasis
Time Frame: Preoperative
Preoperative

Collaborators and Investigators

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

Sponsor

Fudan University

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)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECTOP-1017

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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