Lung NodulesNCT03339479
Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass
A study testing dielectric property test, frozen pathological examination and final pathological examination in people with Lung Nodules and Lung Mass, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodules, Lung Mass
- What is being tested?
- dielectric property test, frozen pathological examination and final pathological examination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2017to 24 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, 510515
Di Lu, MD, PhD, 86+13268379321, david_lu189@163.com
Siyang Feng, MD, 86+13570930671, fengsy89@163.com
About this study
Official title: Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial
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
- Lung Nodules, Lung Mass
- Being tested
- dielectric property test, frozen pathological examination, final pathological examination
- Keywords
- dielectric property, lung nodules, differential diagnosis, frozen pathological examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dielectric property testDiagnostic 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 examinationDiagnostic test
And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.
final pathological examinationDiagnostic test
All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.
| Study group | Role | What they receive |
|---|---|---|
| dielectric property test | Experimental | The patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open. Receives: Diagnostic Test: dielectric property test |
| frozen pathological examination | Placebo comparator | The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test. Receives: Diagnostic Test: frozen pathological examination |
| final pathological examination | Other | The resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination. Receives: Diagnostic Test: final pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of dielectric property test in diagnosing lung nodules/masses
true positive rate in diagnosing lung nodules/masses
Measured: 3-5 years
specificity of dielectric property test in diagnosing lung nodules/masses
true negative rate in diagnosing lung nodules/masses
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start25 May 2017
- Primary completion24 May 2020 (estimated)
- Study completion24 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- self-control method
- Masking
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Di Lu, MD,PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339479
- Sponsor's protocol ID
- NFEC-2017-070
- Status last verified
- May 2018
- First submitted
- 21 Aug 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of dielectric property test, frozen pathological test and final pathological examination of each individual participant.
Publications
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.
PubMed 8938024Gabriel 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.
PubMed 8938025Gabriel 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.
PubMed 8938026Joines 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.
PubMed 8058021Lu 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.
PubMed 1479201Surowiec 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.
PubMed 2834285Fu 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.
PubMed 24417349
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial
- ClinicalTrials.gov ID
- NCT03339479
- Acronym / sponsor ID
- NFEC-2017-070
- Conditions
- Lung Nodules, Lung Mass
- Keywords
- dielectric property, lung nodules, differential diagnosis, frozen pathological examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 24 May 2020 (estimated)
- Study completion
- 24 May 2020 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- self-control method
| Arm | Type | Receives |
|---|---|---|
| dielectric property test | Experimental | Diagnostic Test: dielectric property testThe 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 comparator | Diagnostic Test: frozen pathological examinationThe resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test. |
| final pathological examination | Other | Diagnostic Test: final pathological examinationThe resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dielectric property testTest 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. | Diagnostic test | dielectric property test |
| frozen pathological examinationAnd after the dielectric property test, the lung tissue will be sent for frozen pathological examination. | Diagnostic test | frozen pathological examination |
| final pathological examinationAll of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery. | Diagnostic test | final pathological examination |
Primary outcome
sensitivity of dielectric property test in diagnosing lung nodules/masses
Time frame: 3-5 years
true positive rate in diagnosing lung nodules/masses
specificity of dielectric property test in diagnosing lung nodules/masses
Time frame: 3-5 years
true negative rate in diagnosing lung nodules/masses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 8938024Gabriel 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.
- Background: PubMed 8938025Gabriel 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.
- Background: PubMed 8938026Gabriel 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.
- Background: PubMed 8058021Joines 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.
- Background: PubMed 1479201Lu 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.
- Background: PubMed 2834285Surowiec 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.
- Background: PubMed 24417349Fu 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.
- Individual participant dataSharing planned: Undecided. The results of dielectric property test, frozen pathological test and final pathological examination of each individual participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Di Lu, MD,PhD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dielectric property test, frozen pathological examination and final pathological examination in people with Lung Nodules and Lung Mass, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Lu, MD,PhD (86+13268379321, david_lu1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of dielectric property test in diagnosing lung nodules/masses (time frame: 3-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339479, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.