Transfusional Iron Overload in Children Treated for Cancer

Study ID
STU 052011-028

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • Children's Medical Center-Dallas

Contact
Beverly Kleiber
214-456-6484
beverly.kleiber@childrens.com

Principal Investigator
Daniel Bowers

Summary

This project will consist of a prospective evaluation of 40 patients for levels of iron and evidence of iron overload. These patients will have been treated for cancer with chemotherapy, and received [GreaterThanorequalTo] 100 mL/kg PRBCs during their treatment. all subjects will be at least one year, but no more than 10 years, from the completion of cancer therapy. The information pertaining to the total transfusion volume that each subject received has been gathered from an ongoing retrospective chart review approved by the iRB in March 2009 (iRB# 032009-006). The study will begin with informed consent at the initial study visit, which may coincide with a routine follow-up visit. Patients are generally seen in the Center for Cancer and Blood Disorders at CMC, but follow-up visits for young adults in the survivorship program may also be conducted at clinics at Parkland Hospital and uT Southwestern Medical Center.

Participation in this study is expected to occur over two separate visits. Visit #1 will involve discussion of the study details, informed consent, and a single venipuncture for blood draw once consent is obtained. The total amount of blood drawn from each subject will be 10 mL or 2 teaspoons. This blood will be used to measure ferritin and transferrin saturation. it is necessary that the subject be free of infection or inflammation when the blood test is done. These blood tests do not require to the subject to be fasting.

Visit #2 will consist of the hepatic R2-MRi, which is performed in the radiology department. The MRi does not involve any injections, radiation, or contrast. The hepatic R2- MRi procedure (also known as FerriScan Rapide[RegisteredTM]) takes approximately 10 minutes. The entire visit is estimated to last approximately 60-90 minutes to allow for check-in and other mandatory radiology procedures. The primary outcome will be estimating the prevalence of iron overload (defined as elevated LiC) measured by hepatic R2-MRi. The levels of ferritin and transferrin saturation will be correlated with LiC measurements by hepatic R2-MRi and total transfusion volume.

Definition of iron overload:
- Hepatic R2-MRi with LiC [GreaterThanorequalTo] 7 mg Fe/ gram dry weight
- Ferritin [GreaterThanorequalTo] 1000 ng/mL
- Transferrin saturation [GreaterThanorequalTo] 50%

Participant Eligibility

1) previous diagnosis of cancer;
2) age 5 years and older;
3) total PRBC transfusions received >= 100 mL/kg;
4) treatment regimen included chemotherapy;
5) at least one year, no more than 10 years, following completion of cancer therapy