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High-Tc Susceptometer to Monitor Transfusional Iron Overload

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary M Brittenham, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01241357
First received: November 12, 2010
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
The proposed research project will continue the application and development of a new method (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in the liver. The amount of iron in the liver is the best indicator of the amount of iron in the whole body. Measuring the amount of iron in the body is important because either too much (iron overload) or too little iron (iron deficiency) can be harmful. At present, the most reliable way to measure the amount of iron in the liver is to remove a sample of the liver by biopsy, either by surgery or by using a needle which pierces the skin and liver. Iron stored in the liver can be magnetized to a small degree when placed in a magnetic field. In patients with iron overload, the investigators previous studies have shown that magnetic measurements of liver iron in patients with iron overload are quantitatively equivalent to biochemical determinations on tissue obtained by biopsy. In the past the investigators have developed a device to measure the amount of magnetization, which was called a SQUID (Superconducting QUantum Interference Device) susceptometer. This device was validated and in use for over 20 years. The safety, ease, rapidity and comfort of magnetic measurements make frequent, serial studies technically feasible and practically acceptable to patients. The investigators have now developed a new susceptometer, which uses very similar technology to the SQUID, but the investigators believe is more accurate and precise. This study aims to validate this new instrument. The investigators will do prospective, serial studies of the diagnosis and management of patients with iron overload, including thalassemia major (Cooley's anemia), sickle cell disease, aplastic anemia, myelodysplasia, hereditary hemochromatosis, and other disorders. Funding Source - FDA OOPD.

Condition Intervention Phase
Transfusional Iron Overload
Thalassemia Major
Sickle Cell Disease
Myelodysplastic Syndromes
Aplastic Anemia
Device: Hepatic biomagnetic susceptibility measurement
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: High-Tc Susceptometer to Monitor Transfusional Iron Overload (NSR Device)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Hepatic non-heme iron concentration determined by biomagnetic susceptometry [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary study analysis will be a comparison of the results of measurements of the hepatic storage iron concentration by biomagnetic susceptometry with the results of biochemical analysis of the storage iron concentration in liver tissue.


Secondary Outcome Measures:
  • Serum ferritin concentration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A secondary study analysis will be a comparison of the results of measurements of the hepatic storage iron concentration by biomagnetic susceptometry with the results of measurements of the serum ferritin concentration.


Enrollment: 99
Study Start Date: March 2011
Study Completion Date: May 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation only
This study has a single arm and no intervention.
Device: Hepatic biomagnetic susceptibility measurement
Subjects will first have an ultrasound study to determine the location of the liver and measure the distance from skin surface to the liver. Subjects will then be examined with the high Tc susceptometer to determine the amount of iron in the liver. The entire procedure will usually take one-half hour or less.
Other Names:
  • Hepatic magnetic susceptibility measurement
  • Superconducting biosusceptometry

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Potential participants who are eligible for this study include: (i) patients scheduled for clinically indicated liver transplantation or liver biopsy, (ii) patients with transfusional iron overload followed in adult and pediatric hematology, and (iii) healthy individuals participating as control subjects.
Criteria

Inclusion Criteria:

  • being an adult male, nonpregnant female or child who is scheduled for liver transplantation, has transfusional iron overload or is healthy with no known disorder affecting body iron stores,
  • being of sufficient size for the susceptometer (about 15 kg body weight),
  • being able to lie quietly during the measurement procedure (about 5 to 10 minutes),
  • being either able to give fully informed consent or, if a minor, with a parent or legal guardian who is able to give fully informed consent for participation of the minor.

Exclusion Criteria:

  • any form of magnetic contamination or electrical device which cannot be removed for the magnetic measurement procedure, including jewelry, pacemakers, artificial joints, metal staples, indwelling catheters with metallic components, dental braces or other magnetic objects;
  • obesity, ascites or other conditions in which the liver to surface distance exceeds 25 mm;
  • pregnancy, treatment for mental illness, imprisonment, institutionalization, or any condition that impairs ability to provide fully informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241357

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Gary M. Brittenham, M.D. Columbia University
  More Information

Publications:
Farrell DE, Allen CJ, Whilden MW, Kidane TK, Baig TN, Tripp JH, Brown RW, Sheth A, Brittenham GM. A new instrument designed to measure the magnetic susceptibility of human liver tissue in vivo. IEEE Trans Magnetics 2007;43:3543-3554.
Farrell DE, Allen CJ, Whilden MW, Tripp JH, Usoskin A, Sheth A, Brittenham GM. Magnetic measurement of liver iron stores: engineering aspects of a new scanning susceptometer based on high temperature superconductivity. IEEE Trans Magnetics 2007; 43:4030-4036.

Responsible Party: Gary M Brittenham, MD, James A. Wolff Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01241357     History of Changes
Other Study ID Numbers: AAAE5051  R01FD003702 
Study First Received: November 12, 2010
Last Updated: September 20, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Iron
Iron overload
Hepatic iron concentration
High-temperature superconductivity
Magnetic susceptibility
Susceptometer

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Anemia, Sickle Cell
Thalassemia
Anemia, Aplastic
Iron Overload
Beta-Thalassemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016