## Protocol Section
### Identification Module
**NCT ID:** NCT03339479

**Brief Title:** 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

#### Organization Study ID Info
**ID:** NFEC-2017-070
#### Organization
**Class:** OTHER
**Full Name:** Nanfang Hospital, Southern Medical University
### Status Module
#### Completion Date
**Date:** 2020-05-24

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-10-30

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-27

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-05-24

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-05-25

**Type:** ACTUAL

**Status Verified Date:** 2018-05

#### Study First Post Date
**Date:** 2017-11-13
**Type:** ACTUAL
**Study First Submit Date:** 2017-08-21
**Study First Submit QC Date:** 2017-11-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanfang Hospital, Southern Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Lung Nodules

- Lung Mass

**Keywords:**

- dielectric property

- lung nodules

- differential diagnosis

- frozen pathological examination

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** self-control method

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 502

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: dielectric property test

**Label:** dielectric property test

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: frozen pathological examination

**Label:** frozen pathological examination

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Diagnostic Test: final pathological examination

**Label:** final pathological examination

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dielectric property test

**Description:** 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.

**Name:** dielectric property test

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- frozen pathological examination

**Description:** And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.

**Name:** frozen pathological examination

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- final pathological examination

**Description:** All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.

**Name:** final pathological examination

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** true positive rate in diagnosing lung nodules/masses

**Measure:** sensitivity of dielectric property test in diagnosing lung nodules/masses

**Time Frame:** 3-5 years

**Description:** true negative rate in diagnosing lung nodules/masses

**Measure:** specificity of dielectric property test in diagnosing lung nodules/masses

**Time Frame:** 3-5 years

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** david_lu1989@163.com

**Name:** Di Lu, MD,PhD

**Phone:** 86+13268379321

**Role:** CONTACT

**Contact 2:**

**Email:** fengsy89@163.com

**Name:** Siyang Feng, MD

**Phone:** 86+13570930671

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guandong

**Contacts:**

***Contact 1:***

- **Email:** david_lu189@163.com

- **Name:** Di Lu, MD, PhD

- **Phone:** 86+13268379321

- **Role:** CONTACT

***Contact 2:***

- **Email:** fengsy89@163.com

- **Name:** Siyang Feng, MD

- **Phone:** 86+13570930671

- **Role:** CONTACT

**Country:** China

**Facility:** Nanfang Hospital, Southern Medical University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510515

#### Overall Officials

**Official 1:**

**Affiliation:** Nanfang Hospital, Southern Medical University

**Name:** Di Lu, MD,PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

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

**IPD Sharing:** UNDECIDED

### References Module

#### 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.

**PMID:** 8938024

**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.

**PMID:** 8938025

**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.

**PMID:** 8938026

**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.

**PMID:** 8058021

**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.

**PMID:** 1479201

**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.

**PMID:** 2834285

**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.

**PMID:** 24417349

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Meshes

- ID: D000004194

- Term: Disease

### Misc Info Module

- Version Holder: 2024-05-24
