NCT05970913

Brief Summary

This study is a single-center prospective clinical study that aims to evaluate the predictive value of preoperative 18F-FDG-PET-CT and 18F-FAPI-PET/CT for lymph node metastasis in patients with non-small cell lung cancer. The final pathological results were used to assess the predictive value of PET-CT for lymph node metastasis.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
Last Updated

March 23, 2026

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

July 23, 2023

Last Update Submit

March 19, 2026

Conditions

Non Small Cell Lung CancerLymph Node MetastasisPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Predictive value of 18F-FDG-PET/CT and 18F-FAPI-PET/CT for lymph node metastasis

    from enrollment to 1 month after surgery

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients had non small cell lung cancer who received pathological examination of lymph nodes

You may qualify if:

  • 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.
  • Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
  • No prior radiotherapy or chemotherapy for initial treatment.
  • No history of malignant tumors.

You may not qualify if:

  • Locally advanced or distant metastasis.
  • Pleural dissemination observed during surgery.
  • History of malignant tumors.
  • Received neoadjuvant therapy.
  • Histopathological examination reveals lung malignancies other than non-small cell lung cancer (NSCLC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the MDT board of thoracic cancer

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

November 1, 2023

Primary Completion

March 28, 2026

Study Completion

March 28, 2026

Last Updated

March 23, 2026

Record last verified: 2025-08

Locations

CN(1)