Cancer of EsophagusNCT04046601
Impedance Spectroscopy in Esophageal Cancer
A study testing impedance in people with Cancer of Esophagus, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial summary
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer of Esophagus
- What is being tested?
- impedance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2019to 15 Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known esophageal cancer and planned for endoscopic resection
Who cannot join
- Missing consent / agreement
- Patient in bad condition for endoscopy or endoscopic resection
- Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection whereas advanced neoplasia might lead to an Operation of the esophagus. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and cancer can be sensed by electrical bioimpedance technique.
The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
Read the detailed description
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection (ER) whereas advanced neoplasia might lead to esophagectomy. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and dysplasia can be sensed by electrical bioimpedance technique. The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
- Conditions
- Cancer of Esophagus
- Being tested
- impedance
- Keywords
- impedance, Barrett´s cancer, early detection of cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impedanceDevice
After endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV. 8 gold electrodes have been integrated to the probe. The impedance will be measured in different ways between the elctrodes. There will be 10 measurements in total for each specimen.
| Study group | Role | What they receive |
|---|---|---|
| Impedance | Experimental | every resected tissue will measured by an impedance probe Receives: Device: impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
impedance
value of 17 different frequencies in ohm
Measured: 10 min
Secondary outcomes (1)
differences in impedance
Differences in electrical impedance properties between different stages of early esophageal cancer.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start9 Oct 2019
- Primary completion1 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of EsophagusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observation group: patient who are planned for endoscopic resection because of known esophageal cancer. Immediately after retrieval the resected specimens will be investigated for their electrical impedance properties. The results of the impedance measurement are compared to the histological results.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mate Knabe, MD, Principal investigator, Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046601
- Sponsor's protocol ID
- Barrett08/2019
- Status last verified
- Jan 2023
- First submitted
- 4 Aug 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Blosser S, May A, Welsch L, Ast M, Braun S, Velten T, Biehl M, Tschammer J, Roeb E, Knabe M. Virtual Biopsy by Electrical Impedance Spectroscopy in Barrett's Carcinoma. J Gastrointest Cancer. 2022 Dec;53(4):948-957. doi: 10.1007/s12029-021-00703-0. Epub 2021 Sep 24.
PubMed 34559362
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
- ClinicalTrials.gov ID
- NCT04046601
- Acronym / sponsor ID
- Barrett08/2019
- Conditions
- Cancer of Esophagus
- Keywords
- impedance, Barrett´s cancer, early detection of cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 6 Aug 2019 (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.
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection whereas advanced neoplasia might lead to an Operation of the esophagus. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and cancer can be sensed by electrical bioimpedance technique.
The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
Detailed description
Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection (ER) whereas advanced neoplasia might lead to esophagectomy. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and dysplasia can be sensed by electrical bioimpedance technique. The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observation group: patient who are planned for endoscopic resection because of known esophageal cancer. Immediately after retrieval the resected specimens will be investigated for their electrical impedance properties. The results of the impedance measurement are compared to the histological results.
| Arm | Type | Receives |
|---|---|---|
| Impedance | Experimental | Device: impedanceevery resected tissue will measured by an impedance probe |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Known esophageal cancer and planned for endoscopic resection
Key exclusion criteria (3 listed)
- Missing consent / agreement
- Patient in bad condition for endoscopy or endoscopic resection
- Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy
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 |
|---|---|---|
| impedanceAfter endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV. 8 gold electrodes have been integrated to the probe. The impedance will be measured in different ways between the elctrodes. There will be 10 measurements in total for each specimen. | Device | Impedance |
Primary outcome
impedance
Time frame: 10 min
value of 17 different frequencies in ohm
1 secondary outcome
differences in impedance
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 34559362Blosser S, May A, Welsch L, Ast M, Braun S, Velten T, Biehl M, Tschammer J, Roeb E, Knabe M. Virtual Biopsy by Electrical Impedance Spectroscopy in Barrett's Carcinoma. J Gastrointest Cancer. 2022 Dec;53(4):948-957. doi: 10.1007/s12029-021-00703-0. Epub 2021 Sep 24.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Mate Knabe, MD principal investigator
Sana Klinikum Offenbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impedance in people with Cancer of Esophagus, run by Sana Klinikum Offenbach at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 17 Jan 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impedance (time frame: 10 min). 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 NCT04046601, which also lists 1 linked publication.
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 17 Jan 2023.