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New treatment option for Acute Myeloid Leukemia
Official title PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT02390635
What this study is testing
What is Gadolinium?
Gadolinium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Gd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with newly diagnosed AML
- Non-English speaking people will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English...
You likely can't join if
- 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...
- Patients with secondary or relapsed AML or APL should be excluded.
- Patients with known extramedullary leukemia
See the full eligibility criteria
- Patients with newly diagnosed AML
- Non-English speaking people will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking people.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.