Using advanced imaging to detect extramedullary myeloid leukemia in newly diagnosed acute myeloid leukemia patients
Official title: PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)
Run by M.D. Anderson Cancer Center · NCT02390635 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 77 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | July 15, 2020 |
| Main results expected | September 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT02390635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with newly diagnosed acute myeloid leukemia or acute promyelocytic leukemia.
✕Probably not a fit
Patients with known extramedullary leukemia or those who have received significant prior treatment for leukemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar imaging techniques have shown promise in other studies for detecting cancer, suggesting potential for success.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.