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RecruitingPhase 1

PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia

PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia."
  • "Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia."
  • "To estimate the incidence of extramedullary myeloid leukemia (EML) in patients with newly diagnosed acute myeloid leukemia (AML), including acute promyelocytic leukemia (APL), by imaging criteria using PET/MR (magnetic resonance), whole body MR, and PET/CT."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well PET/MRI, 18F-FDG PET/CT, and whole-body MRI scans find leukemia outside the bone marrow, the soft tissue inside bones. It is for people with newly diagnosed acute myeloid leukemia (AML), a cancer of the blood and bone marrow.

This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia. Extramedullary myeloid leukemia is a type of cancer found outside of the bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone marrow aspirations. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have newly diagnosed AML.
  • You can join if you do not speak English. Translation will help explain the study consent form.

Who can't join

  • You are younger than 18 or weigh more than 400 pounds.
  • You cannot safely have an MRI, have a known allergy to MRI contrast dye, or have an uncontrollable fear of enclosed spaces.
  • You have had more than minimal leukemia treatment. The study defines minimal treatment as leukapheresis (removing white blood cells from blood), hydroxyurea, or cytarabine above 1 gram per square meter of body surface area.
  • You have secondary AML (AML that developed after another condition or treatment), AML that has come back, or acute promyelocytic leukemia (APL), a type of AML.
  • You already have known leukemia outside the bone marrow.
  • You can become pregnant and have a positive pregnancy test.
  • You have diabetes that is not controlled or an eGFR below 30, a test result showing poor kidney function.
  • You are an adult with impaired thinking or understanding, or you are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients with newly diagnosed AML * Non-English speaking subjects will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking subjects. Exclusion Criteria: * Patients with contraindications to MR * Patients with a known allergy to MR contrast agents * Uncontrollable claustrophobia * Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter. * Patients with secondary or relapsed AML or APL should be excluded. * Patients with known extramedullary leukemia * Positive pregnancy test in a female of childbearing potential * Younger than 18 years * Greater than 400 pounds in weight * Patients with uncontrolled diabetes * Cognitive impaired adults or prisoners will be excluded * Estimated glomerular filtration rate (eGFR \<30) will be excluded

Study sites (1)

TX