Exploratory Study to Determine Tissue Alterations of Advanced Hepatocellular Carcinoma Induced by Electromagnetic Waves of Low Energy Amplitude Modulated to Specific Frequencies During Imaging Study by MRI

August 18, 2016 updated by: Frederico Perego Costa, Hospital Sirio-Libanes

This is an exploratory, national, single-center, open-label study, being conducted at the Institute of Education and Research of the Syrian-Lebanese Hospital in collaboration with the Radiology Institute, the Heart Institute of the Faculty of Medicine of São Paulo, Hospital São Paulo UNIFESP, and the Departments of Physics and Mathematics at the University of São Paulo in order to detect the presence of calcium flux change, tumor perfusion and electrical properties of tumor tissue when exposed to RF EMF AM by Cancer-frequency specific in patients with advanced HCC and correlate these findings with hemodynamic changes assessed by non-invasive hemodynamic measurements.

This study aims to demonstrate the presence of three mechanisms (hypothesis) that could be involved in the hemodynamic changes and the specific antitumor effect induced by exposure to RF EMF AM cancer-specific frequency. This study is not intended to study a therapeutic or diagnostic procedure. For this reason, will not be considered evolutionary clinical data during and after the intervention of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Hospital Sirio-Libanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All individuals selected for these studies should be in accordance with the following inclusion criteria:

  • Patients must have a diagnosis of HCC.
  • Presence of the primary or metastatic tumor at the time of the procedure, at least one (1) measurable lesion by RECIST criteria modified located in the hepatic parenchyma and size> 2 cm.
  • Patients with AFP> 400 ng / ml and image feature not need histopathological confirmation. But in patients with active B virus serology, the value of AFP should be greater than 4000 ng / ml. The remaining patients should be histological confirmation of HCC.
  • Patients may be in observation or presence of systemic or intra-hepatic treatment.
  • Minimum age 18 years.
  • be subjected to MRI study without need for sedation.

Exclusion Criteria:

  • Individuals selected for this study will be excluded if they are in accordance with the following exclusion criteria:

    • can not suspend anti-hypertensive drugs or beta blockers for at least 48 hours or be pacemaker carriers or other implantable device.
    • Any restriction known to carry out study of magnetic resonance imaging.
    • menstrual delay, pregnant or breastfeeding.
    • Presence of metal artifacts or implants that can alter the reading of the magnetic signal or heat or move during the MRI procedure.
    • Prior allergic Event Knowledge gadolinium or manganese chloride solution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium channels
Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride
Procedure: Magnetic Resonance + hemodynamic + infusion of gadolinium
Other Names:
  • Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride
Experimental: Tumor perfusion
Magnetic Resonance + hemodynamic + infusion of gadolinium
Procedure: Magnetic Resonance + hemodynamic + infusion of gadolinium
Other Names:
  • Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory study for the determination of tissue changes of advanced hepatocellular carcinoma induced by electromagnetic waves amplitude modulated low energy specific frequencies during image MRIstudy.
Time Frame: 30 min

Procedure 1 - calcium channel They will be provided for ten (10) patients allocated for this study. Patients will undergo a two (2) studies of MRI with a minimum interval of 7 days between the two studies.

Day - 8: according to a study of MRI and hemodynamic evaluation Procedure 2 - tumor perfusion They will be provided for ten (10) patients allocated for this study. Patients will undergo a two (2) studies of MRI with a minimum interval of 7 days between the two studies.

Day - 1: first study of MRI Day - 8: according to a study of MRI and hemodynamic evaluation Procedure 3 - electrical properties of the tumor and metabolomics Procedure 4 - static magnetic field exposure They will be provided for 20 (twenty) patients allocated for this study. Patients will not be subjected to MRI studies.
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2015-75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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