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

55 Participants Needed

Trial Summary

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 data supports the effectiveness of imaging techniques for acute myeloid leukemia treatment?

The study on 18F-FLT PET/CT suggests that this imaging technique can help assess early response to treatment in acute myeloid leukemia patients, potentially predicting clinical outcomes. ^{1 2 3 4 5}

Is it safe to use imaging techniques like CT and MRI for leukemia?

CT scans involve exposure to radiation, which can increase cancer risk, especially in children. MRI does not use radiation and is generally considered safe, but its safety in specific conditions like leukemia needs careful evaluation. ^{2 6 7 8 9}

How does the imaging treatment for acute myeloid leukemia differ from other treatments?

This treatment uses advanced imaging techniques like MRI and PET/CT to assess bone marrow involvement and early response to therapy in acute myeloid leukemia, offering a non-invasive way to monitor disease progression and treatment effectiveness, unlike traditional methods that rely on more invasive procedures like bone marrow biopsies. ^{4 10 11 12 13}

What is the purpose of this trial?

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. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.

Research Team

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Cognitively impaired adults or prisoners

Patients with contraindications to MR

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

MRI and PET/MRI in hematologic malignancies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cranial computerized tomography in childhood leukemia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Acute myeloid leukemia: lack of predictive value of sequential quantitative MR imaging during treatment. [2007]

4. Germany pubmed.ncbi.nlm.nih.gov

Early assessment of response to induction therapy in acute myeloid leukemia using 18F-FLT PET/CT. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Chest low-dose computed tomography in neutropenic acute myeloid leukaemia patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Radiation Exposure From Pediatric CT Scans and Subsequent Cancer Risk in the Netherlands. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Quantitative magnetic resonance (MR) imaging of bone marrow in leukemia]. [2015]

8. China 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]. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Cerebral computed x-ray tomography in acute lymphoblastic leukemia in children]. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Detection of bone marrow involvement in patients with cancer. [2022]

11. Ireland 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. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Bone marrow in leukemia and aplastic anemia: MR imaging before, during, and after treatment. [2015]

13. Ireland pubmed.ncbi.nlm.nih.gov

Whole-body MR imaging of bone marrow. [2005]