PET-CT in AML for Detection of Extramedullary AML Manifestations (PETAML)
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ClinicalTrials.gov Identifier: NCT01278069
Recruitment Status :
First Posted : January 17, 2011
Last Update Posted : September 18, 2013
Technische Universität Dresden
Information provided by (Responsible Party):
Friedrich Stölzel, M.D., Technische Universität Dresden
Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with AML with this finding. Information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in AML so far. This observational trial will include adult patients with newly diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.
Condition or disease
Newly Diagnosed or Relapsed Acute Myeloid Leukemia
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inpatients or Outpatients with newly diagnosed or relapsed AML AML
Patients with newly diagnosed or relapsed AML
AML FAB M0-2, M4-7
Signed informed consent after patient information
Male and female patients with AML age 18-80
18FDG-PET-CT is available within a period of 5 days after diagnosis of AML
AML FAB M3 (Promyelocytic Leukemia)
lacking willingness to cooperate
pregnancy or insufficient contraception
18FDG-PET-CT is not available within a period of 5 days after diagnosis of AML
Medical condition of the patients requires an immediated start of chemotherapy