PET-CT in 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.

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Key information

Conditions

Newly Diagnosed or Relapsed Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Sarcoma, Myeloid

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Acronym: PETAML

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 17, 2011
Registry last updated: Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed