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PETAML: PET-CT in AML for Detection of Extramedullary AML Manifestations

Sponsor
Technische Universität Dresden (Other)
Overall Status
Completed
CT.gov ID
NCT01278069
Collaborator
(none)
93
Enrollment
1
Location
31
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    93 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2013
    Actual Study Completion Date :
    Sep 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus Dresden Saxony Germany 01307

      Sponsors and Collaborators

      • Technische Universität Dresden

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Friedrich Stölzel, M.D., PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations, Technische Universität Dresden
      ClinicalTrials.gov Identifier:
      NCT01278069
      Other Study ID Numbers:
      • TUD-PETAML-043
      First Posted:
      Jan 17, 2011
      Last Update Posted:
      Sep 18, 2013
      Last Verified:
      Sep 1, 2013
      Keywords provided by Friedrich Stölzel, M.D., PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations, Technische Universität Dresden
      Acute myeloid Leukemia
      Myeloid Sarcoma
      Extramedullary Acute myeloid Leukemia
      18FDG-PET-CT
      Additional relevant MeSH terms:
      Leukemia
      Leukemia, Myeloid
      Leukemia, Myeloid, Acute

      Study Results

      No Results Posted as of Sep 18, 2013