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

October 27, 2018 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guandong, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Di Lu, MD,PhD, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2017

Primary Completion (Anticipated)

May 24, 2020

Study Completion (Anticipated)

May 24, 2020

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 27, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2017-070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The results of dielectric property test, frozen pathological test and final pathological examination of each individual participant.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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