Extramedullary Leukemia (EML) in Newly Diagnosed Acute Myeloid Leukemia (AML) is Underreported
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/5/2018 |
| Start Date: | May 2016 |
| End Date: | May 2020 |
| Contact: | Vikas Kundra, MD, PHD |
| Phone: | 713-745-2702 |
PET/CT and Whole Body Magnetic Resonance Imaging (MRI) in Newly Diagnosed Acute Myeloid Leukemia (AML)
The goal of this clinical research study is to learn if positron emission tomography/magnetic
resonance imaging (PET/MRI), positron emission tomography/computed tomography (PET/CT) and
whole body magnetic resonance imaging (MRI) can be used to detect extramedullary myeloid
leukemia (EML). EML 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.
This is an investigational study. The PET/MRI and PET/CT scans on this study are performed
using FDA-approved and commercially available methods. Using these scans to detect EML is
considered investigational.
Up to 55 participants will be enrolled on this study. All will take part at MD Anderson..
resonance imaging (PET/MRI), positron emission tomography/computed tomography (PET/CT) and
whole body magnetic resonance imaging (MRI) can be used to detect extramedullary myeloid
leukemia (EML). EML 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.
This is an investigational study. The PET/MRI and PET/CT scans on this study are performed
using FDA-approved and commercially available methods. Using these scans to detect EML is
considered investigational.
Up to 55 participants will be enrolled on this study. All will take part at MD Anderson..
If you choose to take part in this study, you will have a PET/MRI and PET/CT scan before you
start your regular treatment.
When you arrive at the clinic for your PET/MRI-PET/CT scans, you will receive a
"radioisotope" and a "contrast" solutions by vein to make the images more accurate. If you
feel very nervous, the doctor may give you medication to help calm you down.
You will have the PET/MRI scan, for which you will have to lie on a table in the scanner for
about an hour. In a different room, you have a PET/CT scan, for which you will have to lie on
a table in the scanner for about 30 minutes.
You and your regular doctor will be told if anything unusual is found in your scans, and the
information will be put in your medical record.
Information will also be collected from your medical record for at least 1 year after you
complete the scans.
start your regular treatment.
When you arrive at the clinic for your PET/MRI-PET/CT scans, you will receive a
"radioisotope" and a "contrast" solutions by vein to make the images more accurate. If you
feel very nervous, the doctor may give you medication to help calm you down.
You will have the PET/MRI scan, for which you will have to lie on a table in the scanner for
about an hour. In a different room, you have a PET/CT scan, for which you will have to lie on
a table in the scanner for about 30 minutes.
You and your regular doctor will be told if anything unusual is found in your scans, and the
information will be put in your medical record.
Information will also be collected from your medical record for at least 1 year after you
complete the scans.
Inclusion Criteria:
1. Patients with newly diagnosed AML or acute promyelocytic leukemia (APL)
2. Women of child bearing potential with negative pregnancy test documented
Exclusion Criteria:
1. Patients with contraindications to MR
2. Patients with a creatinine clearance less than 60
3. Patients with a known allergy to MR contrast agents
4. Uncontrollable claustrophobia
5. Recipients of more than minimal anti-leukemia treatment, with minimal treatment
defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter.
6. Patients with secondary or relapsed AML or APL should be excluded.
7. Patients with known extramedullary leukemia
8. Positive pregnancy test
9. Younger than 18 years
10. Greater than 400 pounds in weight
11. Patients with uncontrolled diabetes
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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