NeoplasmsNCT02747225
Measuring the Electrical Properties of Malignant Tissues In Vivo
An observational study of Neoplasms, run by Southern Medical University, China at 1 site in China.
Trial summary
Previously published studies have indicated that there exist difference in electrical properties (EPs), i.e., the conductivity and relative permittivity, between malignant and adjacent normal tissue, which will be useful in the early detection of cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- network analyzer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2018to Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who are diagnosed with cancer disease and about to have an operation to excise the cancer tissues.
Who may be able to join
- Clinical diagnosis of cancer Disease
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Southern medical university
Guangzhou, Guangdong, 510515
Yu Yanhong, Professor
About this study
Official title: Measuring the Electrical Properties of the Malignant Tissues During Cancer Surgeries
Previously published studies have indicated that there exist difference in electrical properties (EPs), i.e., the conductivity and relative permittivity, between malignant and adjacent normal tissue, which will be useful in the early detection of cancers. However the EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo were published. The purpose of this study is to in vivo measure the electrical properties of the malignant tissues.
Read the detailed description
The measurements were safety guaranteed and were conducted during the cancer surgeries. Before the tissue was excised from the patient,the pathologist assisted the operator (already at the operating room) responsible for the measurement.The measurement of malignant and corresponding normal tissues were both performed. The tissues for dielectric properties measurement were classified as normal or malignant by the pathologist based on his own expertise and decision criteria (visual inspection, anatomy) and the per-operative histological examination. The measurements were directly performed on the tissue before excision.The sites of the measured malignant tissues were marked,doubletracked according to the pathological report to make sure the marked sites are malignant. The patient age and tissue temperature at the time of measurement were recorded.
- Conditions
- Neoplasms
- Being tested
- network analyzer
- Keywords
- electrical properties, malignant tissues, in vivo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
network analyzerDevice
The dielectric properties of the tissues were measured using the open-ended coaxial line method. The measurement system consisted of a network analyzer (Model 4395A, Agilent Corp., Santa Clara, CA) associated with an S-parameter test set (Model 87511A, Agilent Corp., Santa Clara, CA). A semi-rigid coaxial line with a diameter of 3.58 mm was connected to the network analyzer system by using a Bayonet Neill-Concelman connector. The other tip of the coaxial line (probe) was placed on the flat bare surface of the tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Conductivity of the Malignant Tissues measured In Vivo
Measured: one year
Relative Permittivity of the Malignant Tissues measured In Vivo
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherman Xuegang Xin, Southern Medical University, China
- Investigators
- Sherman X Xin, professor, Principal investigator, School of Biomedical Engineering,Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747225
- Sponsor's protocol ID
- SXXin-EPs-measurement-in vivo
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Athey T W, Stuchly M A and Stuchly S S. Measurement of radio frequency permittivity of biological tissues with an open-ended coaxial line: Part I. Microwave Theory and Techniques, IEEE Transactions on IEEE Trans 30(1): 82-86, 1982.
Bobowski Jake S, Johnson Thomas. Permittivity measurements of biological samples by an open-ended coaxial line. Progress In Electromagnetics Research B 40: 159-183, 2012.
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.
PubMed 2834285Smith SR, Foster KR, Wolf GL. Dielectric properties of VX-2 carcinoma versus normal liver tissue. IEEE Trans Biomed Eng. 1986 May;33(5):522-4. doi: 10.1109/TBME.1986.325740. No abstract available.
PubMed 3710509Mehta P, Chand K, Narayanswamy D, Beetner D G, Zoughi R and Stoecker W V. Microwave reflectometry as a novel diagnostic tool for detection of skin cancers IEEE Trans. Instrum. Meas. 55: 1309-16, 2006
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Electrical Properties of the Malignant Tissues During Cancer Surgeries
- ClinicalTrials.gov ID
- NCT02747225
- Acronym / sponsor ID
- SXXin-EPs-measurement-in vivo
- Conditions
- Neoplasms
- Keywords
- electrical properties, malignant tissues, in vivo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Collaborators
- Zhujiang Hospital, Nanfang Hospital, Southern Medical University
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- 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.
Previously published studies have indicated that there exist difference in electrical properties (EPs), i.e., the conductivity and relative permittivity, between malignant and adjacent normal tissue, which will be useful in the early detection of cancers. However the EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo were published. The purpose of this study is to in vivo measure the electrical properties of the malignant tissues.
Detailed description
The measurements were safety guaranteed and were conducted during the cancer surgeries. Before the tissue was excised from the patient,the pathologist assisted the operator (already at the operating room) responsible for the measurement.The measurement of malignant and corresponding normal tissues were both performed. The tissues for dielectric properties measurement were classified as normal or malignant by the pathologist based on his own expertise and decision criteria (visual inspection, anatomy) and the per-operative histological examination. The measurements were directly performed on the tissue before excision.The sites of the measured malignant tissues were marked,doubletracked according to the pathological report to make sure the marked sites are malignant. The patient age and tissue temperature at the time of measurement were recorded.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who are diagnosed with cancer disease and about to have an operation to excise the cancer tissues.
Key inclusion criteria (1 listed)
- Clinical diagnosis of cancer Disease
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| network analyzerThe dielectric properties of the tissues were measured using the open-ended coaxial line method. The measurement system consisted of a network analyzer (Model 4395A, Agilent Corp., Santa Clara, CA) associated with an S-parameter test set (Model 87511A, Agilent Corp., Santa Clara, CA). A semi-rigid coaxial line with a diameter of 3.58 mm was connected to the network analyzer system by using a Bayonet Neill-Concelman connector. The other tip of the coaxial line (probe) was placed on the flat bare surface of the tissue. | Device | – |
Primary outcome
Conductivity of the Malignant Tissues measured In Vivo
Time frame: one year
Relative Permittivity of the Malignant Tissues measured In Vivo
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- BackgroundAthey T W, Stuchly M A and Stuchly S S. Measurement of radio frequency permittivity of biological tissues with an open-ended coaxial line: Part I. Microwave Theory and Techniques, IEEE Transactions on IEEE Trans 30(1): 82-86, 1982.
- BackgroundBobowski Jake S, Johnson Thomas. Permittivity measurements of biological samples by an open-ended coaxial line. Progress In Electromagnetics Research B 40: 159-183, 2012.
- 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 3710509Smith SR, Foster KR, Wolf GL. Dielectric properties of VX-2 carcinoma versus normal liver tissue. IEEE Trans Biomed Eng. 1986 May;33(5):522-4. doi: 10.1109/TBME.1986.325740. No abstract available.
- BackgroundMehta P, Chand K, Narayanswamy D, Beetner D G, Zoughi R and Stoecker W V. Microwave reflectometry as a novel diagnostic tool for detection of skin cancers IEEE Trans. Instrum. Meas. 55: 1309-16, 2006
- An Internet resource for the calculation of the dielectric properties of body tissues in the frequency range 10 Hz - 100 GHz Based on data published by C.Gabriel et al. in 1996.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sherman X Xin, professor principal investigator
School of Biomedical Engineering,Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Southern Medical University, China 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 1 inclusion and 1 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 12 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. 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 Sherman X Xin, professor (008613602733465, xxg@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conductivity of the Malignant Tissues measured In Vivo (time frame: one year). 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 NCT02747225, which also lists 5 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 12 Oct 2018.