PET-CT in AML for Detection of Extramedullary AML Manifestations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Keywords

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Acute myeloid Leukemia Myeloid Sarcoma Extramedullary Acute myeloid Leukemia 18FDG-PET-CT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Friedrich Stölzel, M.D.

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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Stolzel F, Rollig C, Radke J, Mohr B, Platzbecker U, Bornhauser M, Paulus T, Ehninger G, Zophel K, Schaich M. (1)(8)F-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.

Reference Type DERIVED

PMID: 21685468 (View on PubMed)

Other Identifiers

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TUD-PETAML-043

Identifier Type: -

Identifier Source: org_study_id