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

Lung Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339479
• Other study ID #: NFEC-2017-070
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2017
• Est. completion date: May 24, 2020

Study information

• Verified date: May 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Di Lu, MD,PhD
• Phone: 86+13268379321
• Email: david_lu1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: May 24, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Mass
• Lung Nodules

Intervention

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.
• frozen pathological examination
And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.
• final pathological examination
All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guandong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

Fu 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. — View Citation

Gabriel C, Gabriel S, Corthout E. The dielectric properties of biological tissues: I. Literature survey. Phys Med Biol. 1996 Nov;41(11):2231-49. Review. — View Citation

Gabriel 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. — View Citation

Gabriel 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. — View Citation

Joines 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. — View Citation

Lu 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. — View Citation

Surowiec 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of dielectric property test in diagnosing lung nodules/masses	true positive rate in diagnosing lung nodules/masses	3-5 years
Primary	specificity of dielectric property test in diagnosing lung nodules/masses	true negative rate in diagnosing lung nodules/masses	3-5 years