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Diagnosis of Rectal Cancer by Electromagnetic Device

Clinical Investigation on a Device for the Diagnosis of Rectal Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963794
Enrollment
442
Registered
2009-08-24
Start date
2008-01-31
Completion date
2008-12-31
Last updated
2009-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal cancer, Population screening, Early detection

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.

Interventions

OTHERElectromagnetic measurement

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.

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026