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

NCT ID: NCT02692365

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Primary or Metastatic Tumor in the Liver Parenchyma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Calcium channels

Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride

Group Type: EXPERIMENTAL

Magnetic Resonance + hemodynamic + infusion of gadolinium

Intervention Type: PROCEDURE

Tumor perfusion

Magnetic Resonance + hemodynamic + infusion of gadolinium

Group Type: EXPERIMENTAL

Magnetic Resonance + hemodynamic + infusion of gadolinium

Intervention Type: PROCEDURE

Interventions

Magnetic Resonance + hemodynamic + infusion of gadolinium

Intervention Type: PROCEDURE

Other Intervention Names

Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Frederico Perego Costa

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HSL 2015-75

Identifier Type: -

Identifier Source: org_study_id