Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass
1 other identifier
interventional
502
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2020
CompletedOctober 30, 2018
May 1, 2018
3 years
August 21, 2017
October 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
dielectric property test
EXPERIMENTALThe patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open.
frozen pathological examination
PLACEBO COMPARATORThe resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test.
final pathological examination
OTHERThe resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination.
Interventions
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.
And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.
All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, 510515, China
Related Publications (7)
Gabriel C, Gabriel S, Corthout E. The dielectric properties of biological tissues: I. Literature survey. Phys Med Biol. 1996 Nov;41(11):2231-49. doi: 10.1088/0031-9155/41/11/001.
PMID: 8938024BACKGROUNDGabriel S, Lau RW, Gabriel C. The dielectric properties of biological tissues: II. Measurements in the frequency range 10 Hz to 20 GHz. Phys Med Biol. 1996 Nov;41(11):2251-69. doi: 10.1088/0031-9155/41/11/002.
PMID: 8938025BACKGROUNDGabriel S, Lau RW, Gabriel C. The dielectric properties of biological tissues: III. Parametric models for the dielectric spectrum of tissues. Phys Med Biol. 1996 Nov;41(11):2271-93. doi: 10.1088/0031-9155/41/11/003.
PMID: 8938026BACKGROUNDJoines WT, Zhang Y, Li C, Jirtle RL. The measured electrical properties of normal and malignant human tissues from 50 to 900 MHz. Med Phys. 1994 Apr;21(4):547-50. doi: 10.1118/1.597312.
PMID: 8058021BACKGROUNDLu Y, Li B, Xu J, Yu J. Dielectric properties of human glioma and surrounding tissue. Int J Hyperthermia. 1992 Nov-Dec;8(6):755-60. doi: 10.3109/02656739209005023.
PMID: 1479201BACKGROUNDSurowiec AJ, Stuchly SS, Barr JB, Swarup A. Dielectric properties of breast carcinoma and the surrounding tissues. IEEE Trans Biomed Eng. 1988 Apr;35(4):257-63. doi: 10.1109/10.1374. No abstract available.
PMID: 2834285BACKGROUNDFu F, Xin SX, Chen W. Temperature- and frequency-dependent dielectric properties of biological tissues within the temperature and frequency ranges typically used for magnetic resonance imaging-guided focused ultrasound surgery. Int J Hyperthermia. 2014 Feb;30(1):56-65. doi: 10.3109/02656736.2013.868534. Epub 2014 Jan 13.
PMID: 24417349BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Di Lu, MD,PhD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2017
First Posted
November 13, 2017
Study Start
May 25, 2017
Primary Completion
May 24, 2020
Study Completion
May 24, 2020
Last Updated
October 30, 2018
Record last verified: 2018-05