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Acute Lymphoblastic LeukemiaEarly Phase 1NCT03422731

Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy

A Early Phase 1 study testing Biospecimen Collection, Dual-Energy Computed Tomography and Fluorothymidine F-18 in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (TBI) and chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Dual-Energy Computed Tomography and Fluorothymidine F-18
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
15 Feb 2018to 6 Nov 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort TMLI+FLT: AML patients eligible for and enrolling on COH 14012 or IRB 17505 that agree to participate in optional FLT PET imaging
  • Note: patients enrolling on IRB 19518 cannot enroll onto this cohort, but they may enroll on Cohort TMLI (below)
  • Cohort TMLI: AML or ALL patients eligible for and enrolling on COH 14012, IRB 17505 or IRB 19518
  • Cohort TBI: First or second remission AML or ALL patients that will receive TBI (13.2 Gy) plus chemotherapy (etoposide [VP16] 60 mg/kg or cyclophosphamide [Cy] 60 mg/kg for two days) as part of their standard of care
  • Cohort TBI: Documented written informed consent of participant
  • Cohort TBI: Age >= 18 to =< 60 years
  • Cohort TBI: Patients who have not received a prior transplant

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Multi-Modality Imaging and Correlative Studies in Patients With Leukemia

This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (TBI) and chemotherapy. Using multi-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Temporal assessment of treatment impact on bone marrow. II. Relative assessment of bone marrow status between total marrow and lymphoid irradiation (TMLI) and conventional TBI.

SECONDARY OBJECTIVES:

  1. Correlation of dual energy computed tomography (DECT), magnetic resonance imaging (MRI) imaging with biological samples for cellularity/adiposity.

II. Feasibility of fluorothymidine F-18 (FLT) positron emission tomography (PET) imaging biomarker as a predictor of treatment response.

III. Correlation of FLT PET imaging with biological correlate for leukemia. IV. Characterize relative distribution of leukemia in bone marrow (BM) environment.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (TLMI+FLT/TMLI): Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.

COHORT II (TBI): Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.

Being tested
Biospecimen Collection, Dual-Energy Computed Tomography, Fluorothymidine F-18, Laboratory Biomarker Analysis, Magnetic Resonance Imaging
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of bone marrow and blood samples

  • Dual-Energy Computed TomographyProcedure or surgery

    Also called DECT

    Undergo DECT

  • Fluorothymidine F-18Drug

    Also called 18F-FLT, 3''-Deoxy-3''-(18F) Fluorothymidine, 3''-deoxy-3''-[18F]fluorothymidine, ALOVUDINE F-18

    Undergo FLT PET

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI

    Undergo water-fat MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo FLT PET

Study groups in NCT03422731
Study groupRoleWhat they receive
Cohort I (TMLI+FLT/TMLI)ExperimentalPatients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.
Receives: Procedure: Biospecimen Collection; Procedure: Dual-Energy Computed Tomography; Drug: Fluorothymidine F-18; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography
Cohort II (TBI)Active comparatorPatients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.
Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change over time in cellularity and adiposity

    A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- standard deviation (SD) at each time point. Exploratory within subjects' correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. Will use a two-sample t-test for comparing bone marrow cellularity percentage at pre-HCT and 1-year post-HCT between the total marrow and lymphoid irradiation (TMLI) group and total body irradiation (TBI) group (all cohorts). A paired t-test will also be carried out to examine if there is significant difference in changes of cellularity between these two groups.

    Measured: Up to 1 year post-hematopoietic stem cell transplant (HCT)

  2. Change over time of red marrow (cellularity) and yellow marrow (adipocyte)

    A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- SD at each time point. Exploratory within subjects' correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. In addition, bone marrow/peripheral blood measurements will be correlated with survival outcome (relapse).

    Measured: Up to 2 years

  3. Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis)

    Will be assessed by HSCs from marrow aspirate.

    Measured: Up to 2 years

  4. Ratio of HSC sub-populations (sub-analysis)

    Long-term, short-term, multi-potent progenitor, common myeloid progenitor, and granulocyte macrophage progenitor will all be assessed by HSCs marrow aspirate.

    Measured: Up to 2 years

  5. Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)

    Will be assessed by CD34 staining.

    Measured: Up to 2 years

  6. Microvascular density in bone marrow biopsy samples (sub-analysis)

    Will be assessed by CD31 staining.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Standardized uptake value (SUV) distribution at different skeletal sites

    Changes in standardized uptake value (SUV) from fluorothymidine F-18 (FLT) positron emission tomography (PET) imaging uptake will be described. The distribution or heterogeneity will be first estimated using medians, ranges, interquartile ranges, means and standard deviations. Kolmogorov-Smirnov test (K-S) test will be performed to examine whether the distribution is the same for different skeletal sites. Also as a side product, sensitivity and specificity of the imaging will be estimated.

    Measured: Baseline

  2. SUV distribution and presence of focal hot spot

    Changes in SUV from FLT-PET imaging uptake will be described. The distribution or heterogeneity will be first estimated using medians, ranges, interquartile ranges, means and standard deviations. K-S test will be performed to examine whether the distribution is the same for different skeletal sites. Also as a side product, sensitivity and specificity of the imaging will be estimated.

    Measured: Baseline

  3. Change in FLT PET activity

    Measured: Baseline up to 2 years

  4. SUVmax at site of biopsy

    SUVmax: the maximum SUV within the region of interest. SUVmin: the minimum SUV within the region of interest. SUVmean: the average SUV within the region of interest. As a primary goal we will be using SUVmax. Other parameters are secondary parameters.

    Sites: site of bone marrow biopsy is iliac crest. Image analysis is done at the different locations - iliac crest, Lumber spine, and femur.

    Measured: At time of biopsy

  5. SUVmean at site of biopsy

    SUVmax: the maximum SUV within the region of interest. SUVmin: the minimum SUV within the region of interest. SUVmean: the average SUV within the region of interest. As a primary goal we will be using SUVmax. Other parameters are secondary parameters.

    Sites: site of bone marrow biopsy is iliac crest. Image analysis is done at the different locations - iliac crest, Lumber spine, and femur.

    Measured: At time of biopsy

  6. Blast counts

    Will be assessed by bone marrow aspirate smears.

    Measured: Up to 2 years

  7. SUVmax at iliac crest, lumber spine, and femur

    For each location SUV measurement, software provides SUVmax, SUVmin and SUVmean. These are not separate measurements. Once region (volume) is defined, software will calculate SUV in the form of SUVmax, SUVmean and SUVmin. For simplicity, we will report SUVmax only as primary parameter. SUVmean and SUVmin will be secondary SUV parameters.

    Measured: Up to 2 years

  8. SUVmean at iliac crest, lumber spine, and femur

    For each location SUV measurement, software provides SUVmax, SUVmin and SUVmean. These are not separate measurements. Once region (volume) is defined, software will calculate SUV in the form of SUVmax, SUVmean and SUVmin. For simplicity, we will report SUVmax only as primary parameter. SUVmean and SUVmin will be secondary SUV parameters.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2018
  2. Study start15 Feb 2018
  3. Primary completion6 Nov 2026 (estimated)
  4. Study completion6 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03422731
Sponsor's protocol ID
17222
Other IDs
NCI-2017-01778, 17222, P30CA033572
Status last verified
Jun 2026
First submitted
2 Oct 2017
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Malekzadeh M, Ghimire H, Popuri K, Fujita K, Salhotra A, Yamauchi D, Chen B, Froelich J, Storme G, Stein A, Beg MF, Wong J, Malki MMA, Hui SK. AI-Driven Bone and Marrow Segmentation on FLT-PET/CT: Technical Multi-organ Validation in AML and HCT. Res Sq [Preprint]. 2026 Apr 19:rs.3.rs-9077609. doi: 10.21203/rs.3.rs-9077609/v1.

    PubMed 42040934

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biospecimen Collection, Dual-Energy Computed Tomography and Fluorothymidine F-18 in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change over time in cellularity and adiposity (time frame: Up to 1 year post-hematopoietic stem cell transplant (HCT)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03422731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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