Clinical trial NCT03339479: Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass
Official title: Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Nodules
Lung Mass
Keywords: dielectric property
lung nodules
differential diagnosis
frozen pathological examination
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: self-control method
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: sensitivity of dielectric property test in diagnosing lung nodules/masses
timeFrame: 3-5 years
measure: specificity of dielectric property test in diagnosing lung nodules/masses
timeFrame: 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guandong
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Di Lu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1088/0031-9155/41/11/001.
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. doi: 10.1088/0031-9155/41/11/002.
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. doi: 10.1088/0031-9155/41/11/003.
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. doi: 10.1118/1.597312.
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. doi: 10.3109/02656739209005023.
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. doi: 10.1109/10.1374. No abstract available.
citation: 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.