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An Epidemiological Study to Assess the Prevalence of Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)


N/A
12 Years
N/A
Not Enrolling
Both
Thalassemia, Non-transfusion Dependent Thalassemia, Myelodysplastic Syndromes, Myelofibrosis, Other Anemia

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Trial Information

An Epidemiological Study to Assess the Prevalence of Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)


Inclusion Criteria:



Age ≥ 12 years Confirmed clinical diagnosis of one of the following disease states: 1.
Myelodysplastic syndromes, 2. Thalassaemia major, 3.Other anaemias (e.g. NTDT, SCD,
Diamond-Blackfan anaemia, aplastic anaemia, myeloproliferative disease) Lifetime history
of at least 20 units of red blood cell transfusions AND serum ferritin level > 500 ng/ml;
patients with NTDT are not required to have a minimum of 20 units of red blood cell
transfusions, but must have serum ferritin level > 300 ng/ml (serum ferritin for all
patients must be measured up to 1 month prior to enrollment) Written informed consent
obtained prior to any procedure required by this protocol

Exclusion Criteria:

Any condition that does not allow the MRI test to be performed: 1. Cardiac pacemaker, 2.
Ferromagnetic metal implants other than those approved as safe for use in MR scanners
(Example: some types of aneurysm clips, shrapnel), 3. Obesity (exceeding the equipment
limits), 4. Patients who are claustrophobic to MR Women who are pregnant Unwillingness or
being unable to give consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Prevalence and severity of liver and cardiac iron overload in patients with transfusional siderosis (MDS, thalassaemia major and other anaemias).

Outcome Description:

Hepatic and cardiac iron overload in patients with transfusional siderosis (MDS, thalassaemia major and other anaemias) will be measured using MRI to measure both liver and cardiac iron loading (R2 by FerriScan and T2*, respectively). Values will be compared to published thresholds of iron overload to determine severity of transfusion siderosis in the patient population studied.

Outcome Time Frame:

12 months - retrospective

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Human Research Ethics Committee

Study ID:

CICL670AAU05

NCT ID:

NCT01736540

Start Date:

January 2013

Completion Date:

August 2014

Related Keywords:

  • Thalassemia, Non-transfusion Dependent Thalassemia, Myelodysplastic Syndromes, Myelofibrosis, Other Anemia
  • Primary Myelofibrosis
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Siderosis
  • Thalassemia
  • Iron Overload

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