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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

Primary Purpose

Primary or Metastatic Tumor in the Liver Parenchyma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Magnetic Resonance + hemodynamic + infusion of gadolinium
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Primary or Metastatic Tumor in the Liver Parenchyma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Sírio-Libanês

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Calcium channels

Tumor perfusion

Arm Description

Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride

Magnetic Resonance + hemodynamic + infusion of gadolinium

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
August 18, 2016
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT02692365
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary or Metastatic Tumor in the Liver Parenchyma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium channels
Arm Type
Experimental
Arm Description
Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride
Arm Title
Tumor perfusion
Arm Type
Experimental
Arm Description
Magnetic Resonance + hemodynamic + infusion of gadolinium
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance + hemodynamic + infusion of gadolinium
Other Intervention Name(s)
Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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