Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass
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|ClinicalTrials.gov Identifier: NCT03339479|
Recruitment Status : 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339479
|Contact: Di Lu, MD,PhDfirstname.lastname@example.org|
|Contact: Siyang Feng, MDemail@example.com|
|Nanfang Hospital, Southern Medical University||Recruiting|
|Guandong, Guangdong, China, 510515|
|Contact: Di Lu, MD, PhD 86+13268379321 firstname.lastname@example.org|
|Contact: Siyang Feng, MD 86+13570930671 email@example.com|
|Principal Investigator:||Di Lu, MD,PhD||Nanfang Hospital of Southern Medical University|