PET-CT Predicting Segement Specific Lymph Nodes Metastasis

NCT ID: NCT05970913

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Lymph Node Metastasis Positron Emission Tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haiquan Chen

Chief of the MDT board of thoracic cancer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hang Li

Role: CONTACT

+862164175590

Facility Contacts

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Hang Li

Role: primary

Other Identifiers

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ECTOP-1017

Identifier Type: -

Identifier Source: org_study_id

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