Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass
|ClinicalTrials.gov Identifier: NCT03339479|
Recruitment Status : Unknown
Verified May 2018 by Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : November 13, 2017
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Nodules Lung Mass||Diagnostic Test: dielectric property test Diagnostic Test: frozen pathological examination Diagnostic Test: final pathological examination||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||502 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||self-control method|
|Masking:||None (Open Label)|
|Official Title:||Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial|
|Actual Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||May 24, 2020|
|Estimated Study Completion Date :||May 24, 2020|
Experimental: 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.
Diagnostic Test: dielectric property test
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.
Placebo Comparator: frozen pathological examination
The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test.
Diagnostic Test: frozen pathological examination
And after the dielectric property test, the lung tissue will be sent for frozen 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.
Diagnostic Test: final pathological examination
All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.
- sensitivity of dielectric property test in diagnosing lung nodules/masses [ Time Frame: 3-5 years ]true positive rate in diagnosing lung nodules/masses
- specificity of dielectric property test in diagnosing lung nodules/masses [ Time Frame: 3-5 years ]true negative rate in diagnosing lung nodules/masses
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339479
|Contact: Di Lu, MD,PhDemail@example.com|
|Contact: Siyang Feng, MDfirstname.lastname@example.org|
|Principal Investigator:||Di Lu, MD,PhD||Nanfang Hospital of Southern Medical University|