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

Study Overview
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Brief Summary
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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.

Official Title
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Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial

Conditions
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Lung Nodules, Lung Mass

Intervention / Treatment
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* Diagnostic Test: dielectric property test
* Diagnostic Test: frozen pathological examination
* Diagnostic Test: final pathological examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: self-control method
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dielectric property test<br>The patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open. | Diagnostic Test: dielectric property test<br>* Test the dielectric property of resected lung nodules/mass through a touching probe after the lung tissue with nodules/mass has been resected and cut open, which usually takes only 1-5 minutes.<br>|
| Placebo Comparator: frozen pathological examination<br>The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test. | Diagnostic Test: frozen pathological examination<br>* And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.<br>|
| Other: final pathological examination<br>The resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination. | Diagnostic Test: final pathological examination<br>* All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of dielectric property test in diagnosing lung nodules/masses | true positive rate in diagnosing lung nodules/masses | 3-5 years | 
| specificity of dielectric property test in diagnosing lung nodules/masses | true negative rate in diagnosing lung nodules/masses | 3-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dielectric property, lung nodules, differential diagnosis, frozen pathological examination