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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Friedrich Stölzel, M.D., Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01278069
First received: January 14, 2011
Last updated: September 16, 2013
Last verified: September 2013
  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 Technische Universität Dresden:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278069

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

No publications provided by Technische Universität Dresden

Additional 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
Study First Received: January 14, 2011
Last Updated: September 16, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Technische Universität Dresden:
Acute myeloid Leukemia
Myeloid Sarcoma
Extramedullary Acute myeloid Leukemia
18FDG-PET-CT

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

ClinicalTrials.gov processed this record on August 19, 2014