Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass

Not Applicable

• Conditions: Lung Mass; Lung Nodules
• Interventions: Diagnostic Test: dielectric property test; Diagnostic Test: frozen pathological examination; Diagnostic Test: final pathological examination

• Registration Number: NCT03339479
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Patients with lung nodules/mass found by CT (computed tomography) or PET (positron emission tomography) who agree to receive lung resection are arranged to test the dielectric property before receiving the frozen pathological examination. And the final pathological results are recognized as the standard diagnosis. Then the sensitivity and specificity of the dielectric property test will be evaluated comparing with the frozen pathological examination.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-25
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Status Verified: 2018-05
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30
• Primary Completion: 2020-05-24
• Study Completion: 2020-05-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

• Patients with lung nodules/mass found by CT or PET who agree to receive lung resection;
• Diameter of the lung nodule/mass is longer than 8 millimeters;
• More than 50% of the lung nodule/mass is solid component by image examination;
• Diameter of the solid component is longer than 5 millimeters by intraoperative exploration.

Exclusion Criteria

• Cutting open the resected nodule/mass will interfered with the pathological examination;
• Diameter of the solid component is shorter than 5 millimeters by intraoperative cutting open;
• Cutting open the lung nodule/mass will cause great damage to the patient, such as inducing allergic shock.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dielectric property test	dielectric property test	The patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open.
frozen pathological examination	frozen pathological examination	The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test.
final pathological examination	final pathological examination	The resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination.

Primary Outcome Measures

Name	Time	Method
specificity of dielectric property test in diagnosing lung nodules/masses	3-5 years	true negative rate in diagnosing lung nodules/masses
sensitivity of dielectric property test in diagnosing lung nodules/masses	3-5 years	true positive rate in diagnosing lung nodules/masses

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guandong, Guangdong, China