Musculoskeletal Ultrasound in Patients With Hematologic Malignancies

August 21, 2026 updated by: Riham Abdelbaset Dawy Maghazy, Assiut University

Musculoskeletal Ultrasonographic Findings in Patients With Hematologic Malignancies: A Diagnostic Imaging Study Protocol

This study evaluates the role and diagnostic value of musculoskeletal ultrasonography (MSUS) in adult patients with hematologic malignancies who present with musculoskeletal symptoms.

Hematologic malignancies (such as leukemia, lymphoma, and multiple myeloma) frequently involve the musculoskeletal system through bone marrow infiltration, bone destruction, or soft-tissue lesions. Musculoskeletal ultrasound is a non-invasive, radiation-free, and high-resolution imaging technique that allows real-time evaluation of joints, muscles, tendons, bursae, and superficial bone changes.

In this study, adult participants with confirmed blood cancers presenting with symptoms such as localized bone pain, joint swelling, muscle pain, or soft-tissue swelling will undergo a dedicated ultrasound examination of symptomatic areas. The study aims to characterize the patterns of musculoskeletal involvement (including cortical breaks, periosteal changes, soft-tissue masses, synovitis, and vascularity on Doppler imaging) and determine how these findings correlate with disease type, clinical presentation, and laboratory parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18 years or older with a confirmed diagnosis of hematologic malignancy (leukemia, lymphoma, or multiple myeloma) established by bone marrow examination, histopathology, and/or immunophenotyping, identified through the Clinical Hematology Unit registry at Assiut University Hospital, who present with musculoskeletal symptoms and undergo musculoskeletal ultrasound evaluation.

Description

Inclusion Criteria:

  • Adult patients (aged 18 years or older) with a confirmed diagnosis of hematologic malignancy (leukemia, lymphoma, or multiple myeloma) established by bone marrow examination, histopathology, and/or immunophenotyping.
  • Patients presenting with musculoskeletal symptoms and undergoing musculoskeletal ultrasonography for the assessment of musculoskeletal involvement at diagnosis or during follow-up.
  • Patients willing and able to provide written informed consent.

Exclusion Criteria:

  • Patients with a prior or concurrent solid organ malignancy with known skeletal metastasis.
  • Patients with a history of major musculoskeletal trauma, orthopedic surgery, or active musculoskeletal infection affecting the examined region.
  • Patients with other connective tissue diseases (e.g., systemic lupus erythematosus, systemic sclerosis).
  • Patients with other inflammatory arthropathies (e.g., psoriatic arthritis, ankylosing spondylitis, reactive arthritis).
  • Patients with incomplete clinical, laboratory, or follow-up data.
  • Patients who decline to participate or withdraw consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with Hematologic Malignancies
Adult patients (aged 18 years or older) with a confirmed diagnosis of hematologic malignancy (leukemia, lymphoma, or multiple myeloma) who present with musculoskeletal symptoms (e.g., bone pain, joint pain/swelling, muscle pain, soft-tissue swelling, limitation of movement, or functional impairment) and undergo diagnostic musculoskeletal ultrasonography (MSK-US) with grayscale B-mode and color/power Doppler imaging to evaluate musculoskeletal involvement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Abnormal Musculoskeletal Ultrasonographic Findings
Time Frame: Baseline
The percentage of participants exhibiting at least one abnormal sonographic finding on B-mode and color/power Doppler musculoskeletal ultrasound in symptomatic regions. Abnormal findings include cortical breaks/erosions, periosteal elevation/subperiosteal collections, focal soft-tissue or intramuscular masses/infiltrative lesions, joint effusion, synovial thickening/hypertrophy, tenosynovitis, or increased Doppler flow vascularity.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSK Ultrasound in Blood Cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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