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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01278069
Acronym
PETAML
Enrollment
93
Registered
2011-01-17
Start date
2011-02-28
Completion date
2013-09-30
Last updated
2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed or Relapsed Acute Myeloid Leukemia

Keywords

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

Brief 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.

Interventions

None listed

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026