NCT00675038

Brief Summary

Many hematological disorders are treated by giving red blood cells. Over a long period of time iron from the red blood cell will accumulate in the tissues of the heart, liver, and endocrine glands. This condition is referred to as iron overload and may become life threatening due to the effects of the iron on these tissues. The normal method for evaluation of iron overload is a liver biopsy. This procedure is invasive and has potential risks, such as bleeding and infection. It is very desirable to establish a method for assessing iron overload which is not invasive. New magnet resonance imaging (MRI) relaxation techniques (T2\*MRI) can be used to indirectly assess the liver iron content and iron in the heart. Results of T2\*MRIs show excellent correlation with liver iron content and heart function. The use of this method of assessment will minimize the risk and inconvenience of liver biopsy and possibly allow more frequent evaluations for iron overload, thus better treatment for these patients. Participants in this study will undergo both liver biopsy for liver iron content and T2\* MRI of the liver and the heart. Results from the procedures performed in this study will be compared, with the end result being the possible elimination of invasive procedures to diagnose iron overload.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

May 6, 2008

Last Update Submit

September 14, 2011

Conditions

Hematological Diseases

Study Arms (1)

1

Study participants will be patients who are cared for by the St. Jude Hematology Division and have developed iron overload and require liver biopsy.

Procedure: Liver Biopsy and MRI T2* MRI

Interventions

Liver Biopsy and MRI T2* MRIPROCEDURE

Evaluation of iron overload with liver biopsy vs. MRI T2\* MRI

1

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinic

You may qualify if:

  • Participant is greater than or equal to 7 years of age
  • Participant needs a liver biopsy for monitoring iron overload
  • Participant is willing to have magnetic resonance testing

You may not qualify if:

  • Patients with surgical clips placed in the United States after August 15th 1996 will be eligible to participate on the study.
  • Contraindication to performing magnetic resonance testing, such as the presence of ferromagnetic material in the body
  • Cannot tolerate an MRI without sedation or anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

  • Hankins JS, McCarville MB, Hillenbrand CM, Loeffler RB, Ware RE, Song R, Smeltzer MP, Joshi V. Ventricular diastolic dysfunction in sickle cell anemia is common but not associated with myocardial iron deposition. Pediatr Blood Cancer. 2010 Sep;55(3):495-500. doi: 10.1002/pbc.22587.

    PMID: 20658621DERIVED

  • Hankins JS, Smeltzer MP, McCarville MB, Aygun B, Hillenbrand CM, Ware RE, Onciu M. Patterns of liver iron accumulation in patients with sickle cell disease and thalassemia with iron overload. Eur J Haematol. 2010 Jul;85(1):51-7. doi: 10.1111/j.1600-0609.2010.01449.x. Epub 2010 Mar 31.

    PMID: 20374273DERIVED

  • Hankins JS, McCarville MB, Loeffler RB, Smeltzer MP, Onciu M, Hoffer FA, Li CS, Wang WC, Ware RE, Hillenbrand CM. R2* magnetic resonance imaging of the liver in patients with iron overload. Blood. 2009 May 14;113(20):4853-5. doi: 10.1182/blood-2008-12-191643. Epub 2009 Mar 4.

    PMID: 19264677DERIVED

Related Links

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Jane Hankins, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

October 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

US(1)