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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Lung Mass; Lung Nodules

Treatments: Diagnostic Test: final pathological examination; Diagnostic Test: frozen pathological examination; Diagnostic Test: dielectric property test

Study type: Interventional

Funder types: Other

Identifiers

NCT03339479

NFEC-2017-070

Details and patient eligibility

About

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.

Enrollment: 502 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 3 patient groups, including a placebo group

dielectric property test

Experimental group

Description:

The patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open.

Treatment:

Diagnostic Test: dielectric property test

frozen pathological examination

Placebo Comparator group

Description:

The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test.

Treatment:

Diagnostic Test: frozen pathological examination

final pathological examination

Other group

Description:

The resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination.

Treatment:

Diagnostic Test: final pathological examination