PET-CT in AML for Detection of Extramedullary AML Manifestations

Newly Diagnosed or Relapsed Acute Myeloid Leukemia Clinical Trial

— PETAML  

Official title:

PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278069
• Other study ID #: TUD-PETAML-043
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: September 16, 2013
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Locations

Country	Name	City	State
Germany	Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany,