High-Tc Susceptometer to Monitor Transfusional Iron Overload

NCT01241357 | Completed

• 2 other identifiers: AAAE5051R01FD003702
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transfusional Iron Overload; Thalassemia Major; Sickle Cell Disease; Myelodysplastic Syndromes; Aplastic Anemia

Keywords

Iron; Iron overload; Hepatic iron concentration; High-temperature superconductivity; Magnetic susceptibility; Susceptometer

Outcome Measures

Primary Outcomes (1)

• Hepatic non-heme iron concentration determined by biomagnetic susceptometry

  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.

  2 years

Secondary Outcomes (1)

• Serum ferritin concentration

  2 years

Study Arms (1)

Observation only

This study has a single arm and no intervention.

Device: Hepatic biomagnetic susceptibility measurement

Interventions

Hepatic biomagnetic susceptibility measurement DEVICE

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.

Also known as: Hepatic magnetic susceptibility measurement, Superconducting biosusceptometry

Observation only

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia; Anemia, Sickle Cell; Myelodysplastic Syndromes; Anemia, Aplastic; Iron Overload

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Marrow Diseases; Bone Marrow Failure Disorders; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gary M. Brittenham, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James A. Wolff Professor of Pediatrics

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: March 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: May 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

US (1)