PET-CT in AML for Detection of Extramedullary AML Manifestations

Completed

• Conditions: Newly Diagnosed or Relapsed Acute Myeloid Leukemia

• Registration Number: NCT01278069
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Study Start: 2011-02
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Saxony, Germany