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Impedance Spectroscopy in Esophageal Cancer

Primary Purpose

Cancer of Esophagus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
impedance
Sponsored by
Sana Klinikum Offenbach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer of Esophagus focused on measuring impedance, Barrett´s cancer, early detection of cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Known esophageal cancer and planned for endoscopic resection

Exclusion Criteria:

  1. Missing consent / agreement
  2. Patient in bad condition for endoscopy or endoscopic resection
  3. Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy

Sites / Locations

  • Sana Clinic Offenbach

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Impedance

Arm Description

every resected tissue will measured by an impedance probe

Outcomes

Primary Outcome Measures

impedance
value of 17 different frequencies in ohm

Secondary Outcome Measures

differences in impedance
Differences in electrical impedance properties between different stages of early esophageal cancer.

Full Information

First Posted
August 4, 2019
Last Updated
January 13, 2023
Sponsor
Sana Klinikum Offenbach
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1. Study Identification

Unique Protocol Identification Number
NCT04046601
Brief Title
Impedance Spectroscopy in Esophageal Cancer
Official Title
Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sana Klinikum Offenbach

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Esophagus
Keywords
impedance, Barrett´s cancer, early detection of cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
no masking
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impedance
Arm Type
Experimental
Arm Description
every resected tissue will measured by an impedance probe
Intervention Type
Device
Intervention Name(s)
impedance
Intervention Description
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.
Primary Outcome Measure Information:
Title
impedance
Description
value of 17 different frequencies in ohm
Time Frame
10 min
Secondary Outcome Measure Information:
Title
differences in impedance
Description
Differences in electrical impedance properties between different stages of early esophageal cancer.
Time Frame
10 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known esophageal cancer and planned for endoscopic resection Exclusion Criteria: Missing consent / agreement Patient in bad condition for endoscopy or endoscopic resection Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mate Knabe, MD
Organizational Affiliation
Sana Klinikum Offenbach
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sana Clinic Offenbach
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63609
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
Data access request will be discussed by an internal board . Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
34559362
Citation
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.
Results Reference
derived

Learn more about this trial

Impedance Spectroscopy in Esophageal Cancer

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