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PET-CT in AML for Detection of Extramedullary AML Manifestations (PETAML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278069
First Posted: January 17, 2011
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Friedrich Stölzel, M.D., Dresden University of Technology
  Purpose
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
Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Friedrich Stölzel, M.D., Dresden University of Technology:

Enrollment: 93
Study Start Date: February 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inpatients or Outpatients with newly diagnosed or relapsed AML AML
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278069


Locations
Germany
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friedrich Stölzel, M.D., PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT01278069     History of Changes
Other Study ID Numbers: TUD-PETAML-043
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Friedrich Stölzel, M.D., Dresden University of Technology:
Acute myeloid Leukemia
Myeloid Sarcoma
Extramedullary Acute myeloid Leukemia
18FDG-PET-CT

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms