Using advanced imaging to detect extramedullary myeloid leukemia in newly diagnosed acute myeloid leukemia patients
PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)
This study is testing new imaging methods to see if they can help find extramedullary myeloid leukemia in people who have just been diagnosed with acute myeloid leukemia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02390635 on ClinicalTrials.gov |
What this trial studies
This pilot phase I trial evaluates the effectiveness of positron emission tomography/magnetic resonance imaging (PET/MRI), 18F-FDG PET/computed tomography (CT), and whole body MRI in identifying extramedullary myeloid leukemia (EML) in patients newly diagnosed with acute myeloid leukemia (AML). The study aims to estimate the incidence of EML using these imaging techniques and correlate the findings with clinical outcomes such as treatment response and relapse patterns. Patients will receive gadolinium intravenously and undergo a series of imaging procedures before starting their treatment for AML. Follow-up assessments will be conducted periodically after the imaging procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with newly diagnosed acute myeloid leukemia or acute promyelocytic leukemia.
Not a fit: Patients with known extramedullary leukemia or those who have received significant prior treatment for leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection of extramedullary myeloid leukemia, leading to better treatment strategies and outcomes for patients with acute myeloid leukemia.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies for detecting cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dawid Schellingerhout — M.D. Anderson Cancer Center
- Study coordinator: Dawid Schellingerhout, MD
- Email: dawid.schellingerhout@mdanderson.org
- Phone: (713) 794-5673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.