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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
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: self-control method
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. sensitivity of dielectric property test in diagnosing lung nodules/masses [ Time Frame: 3-5 years ]
    true positive rate in diagnosing lung nodules/masses

  2. specificity of dielectric property test in diagnosing lung nodules/masses [ Time Frame: 3-5 years ]
    true negative rate in diagnosing lung nodules/masses



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Di Lu, MD,PhD 86+13268379321 david_lu1989@163.com
Contact: Siyang Feng, MD 86+13570930671 fengsy89@163.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guandong, Guangdong, China, 510515
Contact: Di Lu, MD, PhD    86+13268379321    david_lu189@163.com   
Contact: Siyang Feng, MD    86+13570930671    fengsy89@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Di Lu, MD,PhD Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03339479     History of Changes
Other Study ID Numbers: NFEC-2017-070
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The results of dielectric property test, frozen pathological test and final pathological examination of each individual participant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanfang Hospital of Southern Medical University:
dielectric property
lung nodules
differential diagnosis
frozen pathological examination