PET-CT Predicting Lymph Nodes Metastasis | NCT05970913

Studies
PET-CT Predicting Lymph Nodes Metastasis

NCT05970913

Sponsor

Fudan University

Status

Active, not recruiting

Last Update Posted

Mar 23, 2026Actual

Enrollment

280Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer
Lymph Node Metastasis
Positron Emission Tomography

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Mar 28, 2026Estimated

Completion Date

Mar 28, 2026Estimated

First Submitted Date

Jul 23, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

280Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictive value of 18F-FDG-PET/CT and 18F-FAPI-PET/CT for lymph node metastasis		from enrollment to 1 month after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008207	Lymphatic Metastasis

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

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Browse Branches

Not provided