Diagnosis of Rectal Cancer by Electromagnetic Device
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Electromagnetic measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Cancer focused on measuring Rectal cancer, Population screening, Early detection
Eligibility Criteria
Inclusion Criteria:
- Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.
Exclusion Criteria:
- Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Sites / Locations
- Fondazione IRCCS Istituto Nazionale Tumori
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Electromagnetic measurement
Arm Description
Electromagnetic measurement to detect rectal cancer.
Outcomes
Primary Outcome Measures
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Secondary Outcome Measures
Full Information
NCT ID
NCT00963794
First Posted
August 20, 2009
Last Updated
August 21, 2009
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT00963794
Brief Title
Diagnosis of Rectal Cancer by Electromagnetic Device
Official Title
Clinical Investigation on a Device for the Diagnosis of Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal < 50 units (U).
Detailed Description
Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, Population screening, Early detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic measurement
Arm Type
Other
Arm Description
Electromagnetic measurement to detect rectal cancer.
Intervention Type
Other
Intervention Name(s)
Electromagnetic measurement
Other Intervention Name(s)
TrimProb
Intervention Description
RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Primary Outcome Measure Information:
Title
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gastrointestinal disease or clinical symptoms related to colorectal cancer risk.
Exclusion Criteria:
Age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milan
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://www.istitutotumori.mi.it/
Description
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
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Diagnosis of Rectal Cancer by Electromagnetic Device
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