Imaging Techniques for Acute Myeloid Leukemia

Overseen By Dawid Schellingerhout, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Secondary AML, Relapsed AML, APL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the detection of extramedullary myeloid leukemia, a type of cancer that appears outside the bone marrow and is difficult to identify with standard tests. Researchers are evaluating imaging techniques such as PET/MRI and PET/CT scans to determine their effectiveness in detecting this cancer in patients newly diagnosed with acute myeloid leukemia (AML). The trial seeks participants who have been newly diagnosed with AML and have received minimal treatment. As a Phase 1 trial, the research focuses on understanding how the detection methods work in people, offering participants the opportunity to be among the first to benefit from these new techniques.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving more than minimal anti-leukemia treatment, you may not be eligible to participate.

What prior data suggests that these imaging techniques are safe for detecting extramedullary myeloid leukemia?

Research has shown that 18F-FDG PET/CT scans are both helpful and safe for detecting extramedullary acute myeloid leukemia (AML). One study found this method accurately identifies cases with few errors. Studies have also confirmed the safety of whole-body PET/MRI. Although MRI is generally safe, rare side effects can occur. For instance, an MRI once caused a burn in a patient, but such events are uncommon. Both imaging methods are widely used in medical practice, indicating they are well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging techniques for acute myeloid leukemia (AML) because they offer a non-invasive way to assess the disease more precisely. Unlike traditional methods like bone marrow biopsies, these advanced imaging techniques, such as 18F-FDG PET/CT and whole-body PET/MRI, provide a comprehensive view of the entire body, potentially detecting cancerous activity that might be missed otherwise. The use of gadolinium and diffusion-weighted imaging allows for better differentiation between healthy and cancerous tissues, which could lead to more tailored and effective treatment plans. These techniques could revolutionize how AML is monitored and managed, offering hope for earlier and more accurate detection.

What evidence suggests that these imaging techniques are effective for detecting extramedullary myeloid leukemia?

This trial will evaluate imaging techniques like PET and MRI for detecting extramedullary myeloid leukemia, a type of cancer occurring outside the bone marrow. Participants will undergo 18F-FDG PET/CT scans, which have effectively identified this cancer in small patient groups, sometimes more successfully than other methods. PET scans use a special dye to highlight cancer cells, making them easier to detect. Additionally, participants will receive whole-body PET/MRI, which provides detailed images that aid in diagnosis, even though it may not always be the most sensitive method. These imaging tools show promise for better diagnosing and understanding acute myeloid leukemia. ^{6 7 8 9 10}

Who Is on the Research Team?

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL). Women who can have children must show a negative pregnancy test to participate.

Inclusion Criteria

I have been recently diagnosed with AML or APL.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

I am under 18 years old.

Patients with contraindications to MR

Cognitively impaired adults or prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients receive gadolinium IV and undergo whole body PET/MRI and 18F-FDG PET/CT to detect extramedullary myeloid leukemia

1 week

1 visit (in-person)

Follow-up

Participants are monitored periodically for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Magnetic Resonance Imaging
• Positron Emission Tomography

Trial Overview The study tests how well PET/MRI, 18F-FDG PET/CT, and whole body MRI detect extramedullary myeloid leukemia in new AML patients. These imaging techniques may improve diagnosis of cancer outside the bone marrow.

How Is the Trial Designed?

Group I: Diagnostic (18F-FDG PET/CT, whole body PET/MRI) Experimental Treatment 7 Interventions

Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Bone marrow biopsy remains the preferred method for diagnosing both hematologic malignancies and metastatic tumors in the bone marrow, highlighting its critical role in cancer evaluation.

MRI is increasingly recognized for its high sensitivity in detecting hidden disease in the bone marrow, particularly for diagnosing multiple myeloma and assessing lymphoma, despite challenges related to cost and availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of bone marrow involvement in patients with cancer. Federico, M., Magin, RL., Swartz, HM., et al.[2022]

Whole-body MRI has emerged as a fast and effective alternative to traditional multimodal imaging techniques for detecting bone marrow malignancies, allowing for complete imaging in under one hour.

The use of advanced imaging techniques, such as T1-weighted and turbo-STIR sequences, enables high-resolution visualization of bone marrow, improving the ability to distinguish between benign and malignant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body MR imaging of bone marrow. Schmidt, GP., Schoenberg, SO., Reiser, MF., et al.[2005]

3 Tesla MRI demonstrated a high diagnostic accuracy for detecting pneumonia and lung infiltrates in neutropenic patients with acute myeloid leukemia, achieving a sensitivity of 82.3% and specificity of 78.6%.

While MRI effectively identified infectious nodules and consolidations, it struggled with detecting ground glass opacity areas compared to high-resolution CT, highlighting a limitation in its diagnostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3 Tesla proton MRI for the diagnosis of pneumonia/lung infiltrates in neutropenic patients with acute myeloid leukemia: initial results in comparison to HRCT. Attenberger, UI., Morelli, JN., Henzler, T., et al.[2019]

Magnetic resonance studies revealed distinct changes in cervical bone marrow in patients with aplastic anemia and chronic granulocytic leukemia, indicating that MR imaging can help differentiate between healthy and diseased marrow.

The study suggests that monitoring these changes during treatment could provide valuable insights into the effects of chemotherapy and radiation, potentially aiding in predicting treatment outcomes for hematologic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow in leukemia and aplastic anemia: MR imaging before, during, and after treatment. McKinstry, CS., Steiner, RE., Young, AT., et al.[2015]

The study examined 30 patients (20 with lymphoid leukemia and 10 with myeloid leukemia) using MR imaging to assess the signal intensity ratio (SIR) of spinal marrow, finding no significant difference between the two types of leukemia.

While the SIR was not effective in distinguishing between lymphoid and myeloid leukemia, it was found to correlate negatively with tumor burden, indicating its potential use in evaluating the severity of leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quantitative magnetic resonance (MR) imaging of bone marrow in leukemia]. Shen, J., Liang, BL.[2015]

A study of 142 CT brain scans in children with acute lymphoblastic leukemia suggests that initial scans should be done without contrast media to establish a baseline, and follow-up scans are recommended at the end of the third year of treatment to check for iatrogenic lesions.

For neurological complications or suspected leucoblastic meningitis, scans with contrast media are necessary for diagnosis and treatment evaluation, although CT scans have limitations in detecting purely meningeal leucoblastic infiltration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cerebral computed x-ray tomography in acute lymphoblastic leukemia in children]. Nelson, JR., Guibert-Tranier, F., Caille, JM., et al.[2016]

A case study highlights the importance of CT scans in detecting leukemic infiltrates in the brain of children with leukemia, suggesting that early scans could significantly improve treatment outcomes.

Routine CT scans are recommended for children with prolonged remission from leukemia to check for potential reservoirs of leukemia cells in the central nervous system (CNS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial computerized tomography in childhood leukemia. Curless, RG.[2019]

Dynamic contrast-enhanced magnetic resonance imaging (CEMRI) is effective in evaluating diffuse tumor infiltration of bone marrow in patients with acute leukemia, showing significantly higher Emax and Slope values compared to healthy controls.

CEMRI results correlate with treatment outcomes, as Emax and Slope values decreased significantly in patients who achieved complete or partial remission, indicating its potential as a valuable tool for monitoring treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Evaluating Diffuse Tumor Infiltration of Bone Marrow in Patients with Acute Leukemia]. Liu, DH., Wang, JQ., Wu, XQ., et al.[2018]

In a study of 10 adult patients with acute myeloid leukemia (AML) who underwent 18F-FLT PET/CT after induction therapy, the imaging technique effectively distinguished between patients with resistant disease and those in remission, showing good sensitivity and negative-predictive value.

The results indicated that 18F-FLT PET/CT could serve as a valuable noninvasive tool for early treatment response assessment and may help predict clinical outcomes, as PET-positive patients were more likely to experience relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early assessment of response to induction therapy in acute myeloid leukemia using 18F-FLT PET/CT. Han, EJ., Lee, BH., Kim, JA., et al.[2020]

In a study of 168,394 children who underwent CT scans, researchers found that exposure to low-dose ionizing radiation from these scans significantly increased the risk of developing brain tumors, with an average cumulative brain dose of 38.5 mGy linked to this risk.

However, the study did not find any association between cumulative bone marrow dose from CT scans and the risk of leukemia, indicating that while brain tumor risk is a concern, leukemia may not be affected by CT-related radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Exposure From Pediatric CT Scans and Subsequent Cancer Risk in the Netherlands. Meulepas, JM., Ronckers, CM., Smets, AMJB., et al.[2022]

Whole-body MRI (WB-MRI) is a highly sensitive and clinically endorsed method for assessing and staging myeloma, making it a valuable tool in the management of this hematological malignancy.

In contrast, WB-MRI is not recommended for lymphoma and leukemia outside of clinical trials, with current standards favoring other imaging techniques like [18F]FDG-PET/CT for lymphoma and no recommended imaging for leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI and PET/MRI in hematologic malignancies. Mayerhoefer, ME., Archibald, SJ., Messiou, C., et al.[2022]

In a study of 29 patients with acute myeloid leukemia (AML), magnetic resonance imaging (MRI) showed significant changes in bulk T1 values during treatment, indicating alterations in bone marrow cellularity.

However, these changes in bulk T1 did not reliably predict treatment response, as both responders and nonresponders exhibited similar patterns in T1 value changes throughout the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute myeloid leukemia: lack of predictive value of sequential quantitative MR imaging during treatment. Vande Berg, BC., Schmitz, PJ., Scheiff, JM., et al.[2007]

In a study of 40 neutropenic patients with acute myeloid leukaemia, low-dose computed tomography (LDCT) detected abnormalities in 95% of cases, compared to 77.5% with chest radiography (CXR), highlighting LDCT's superior efficacy in identifying pulmonary complications.

The use of LDCT led to changes in clinical management for 27.5% of patients, demonstrating its potential impact on treatment decisions while providing reduced radiation exposure compared to conventional CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chest low-dose computed tomography in neutropenic acute myeloid leukaemia patients. Patsios, D., Maimon, N., Chung, T., et al.[2019]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/16078454.2020.1781500

Full article: The diagnostic and prognostic value of MRI in ... MRI manifestation of central infiltration in AML patients has certain characteristic findings, which is helpful to improve the diagnostic efficiency.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32567523/

The diagnostic and prognostic value of MRI in central ... Sensitivity of MRI in diagnosing AML central infiltration was 36.90%. Despite of its low sensitivity, it still had superior diagnostic value on some patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11477936/

Determinants of Outcomes for Acute Myeloid Leukemia ... Patients receiving high-intensity induction at specialized centers had improved median survivals of 31 months versus 18 months [P<0.001] at non- ...

4. haematologica.org haematologica.org/article/view/11775

Outcome of adult acute myeloid leukemia patients with ... One-year and 2-year overall survival rates were 29.3% (95% CI: 18.6-46.2%) and 12.3% (95% CI: 5.5-27.6%), respectively. Age, with a cutoff of 60 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2152265024024479

Clinical Outcomes of Patients With Newly Diagnosed Acute ... The 5-year OS rate in the entire cohort was 30 % (35 % in patients <60 years and 16 % if ≥60 years), with 92 % of deaths attributed to AML-related complications ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7271590/

The prevalence of extramedullary acute myeloid leukemia ... According to our results, 18FDG-PET/CT is a useful and safe tool to detect EM AML with a high sensitivity and specificity of 77% and 97%, respectively. While ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119442237

PET-CT Scan for Detection of Extramedullary Acute ... The aim of this pilot study was to perform 18FDG-PET-CT scans on patients with newly diagnosed AML as well as relapsed AML in order to study its ...

8. aetna.com aetna.com/cpb/medical/data/1_99/0071.html

Positron Emission Tomography (PET) - Medical Clinical ... Fluorodeoxy-D-glucose (FDG)-PET scans are considered medically necessary for the determination of myocardial viability prior to re-vascularization, either as a ...

9. haematologica.org haematologica.org/article/view/9430/68883

The prevalence of extramedullary acute myeloid leukemia ... A total of 93 patients with. AML underwent 18FDG-PET/CT scans at diagnosis.The prevalence of PET- positive EM AML was 19% with a total of 65 EM AML ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3186319/

18F-FDG-PET/CT for detection of extramedullary acute ... In two retrospective studies of 5 and 6 patients with EM-AML, 18F-FDG-PET was more or at least equally effective in the detection of extramedullary disease.