Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 14, 2011
September 16, 2013
February 2011
September 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01278069 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PET-CT in AML for Detection of Extramedullary AML Manifestations
PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Inpatients or Outpatients with newly diagnosed or relapsed AML AML

Newly Diagnosed or Relapsed Acute Myeloid Leukemia
Not Provided
Not Provided
Stölzel F, Röllig C, Radke J, Mohr B, Platzbecker U, Bornhäuser M, Paulus T, Ehninger G, Zöphel K, Schaich M. ¹⁸F-FDG-PET/CT for detection of extramedullary acute myeloid leukemia. Haematologica. 2011 Oct;96(10):1552-6. doi: 10.3324/haematol.2011.045047. Epub 2011 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01278069
TUD-PETAML-043
No
Friedrich Stölzel, M.D., Dresden University of Technology
Technische Universität Dresden
Not Provided
Not Provided
Technische Universität Dresden
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP