What side effects are associated with this type of intervention?

Bone marrow biopsies commonly result in side effects such as pain at the biopsy site, bleeding, infection, and bruising. The use of ultrasound-assisted techniques may help reduce these risks by improving the accuracy of needle placement, potentially leading to less pain and fewer procedural complications.

What prior FDA approvals exist?

There are no specific FDA approvals or related drugs mentioned for the treatment of bone marrow biopsy procedures, including those using ultrasound-assisted techniques for accurate identification of the PSIS. The focus is on the methodology and potential benefits of using ultrasound to improve the accuracy and outcomes of the biopsy procedure.

What other types of research exist?

Promising novel alternatives to the Ultrasound-Assisted Technique for Bone Marrow Biopsy include the use of advanced imaging modalities such as MRI-guided biopsies and CT-guided biopsies. These techniques can provide high-resolution images and precise localization, potentially improving the accuracy of the biopsy procedure and patient outcomes.

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Ultrasound-Assisted vs. Landmark Bone Marrow Biopsy Techniques (LUMP Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for improving bone marrow biopsy procedures include the use of the Arrow® OnControl® Powered Bone Access System and ultrasound-assisted techniques. The ultrasound-assisted technique is particularly significant as it allows for precise identification of the posterior superior iliac spine (PSIS), ensuring accurate needle placement. This precision reduces procedural errors and enhances the quality of the biopsy sample, which is critical for accurate diagnosis and effective treatment planning for patients.

N/A

Recruiting

Led By Devin Madenberg, DO

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inpatient at Froedtert & MCW Froedtert Hospital ≥18 years old

Bone marrow biopsy is being performed for the explicit purpose of hematology/oncology assessment

Must not have

Inpatient at Froedtert & MCW Froedtert Hospital <18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at the end of the study, estimated to be at 2 years. samples will be analyzed by a pathologist once all samples from 100 participants are obtained.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using ultrasound to guide bone marrow biopsies improves sample quality and reduces patient pain. It targets patients needing biopsies for blood disorders. Ultrasound helps doctors find the best spot for the biopsy, aiming for better outcomes and fewer complications.

Who is the study for?

This trial is for adult patients at Froedtert Hospital who need a bone marrow biopsy for blood or cancer conditions and can give consent. It's not for those under 18, without a biopsy indication, with BMI ≥ 40, or unable to consent.

What is being tested?

The study compares traditional palpation method versus ultrasound-assisted technique in performing bone marrow biopsies. It aims to see if using ultrasound improves the procedure by reducing pain and increasing sample quality.

What are the potential side effects?

While the document doesn't specify side effects, generally bone marrow biopsies can cause pain at the puncture site, bleeding, bruising, infection risk and rarely long-lasting discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and admitted to Froedtert & MCW Froedtert Hospital.

Select...

I am getting a bone marrow biopsy for cancer assessment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 and admitted to Froedtert & MCW Froedtert Hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at the end of the study, estimated to be at 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at the end of the study, estimated to be at 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at the end of the study, estimated to be at 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core adequacy

Secondary study objectives

Aspirate adequacy

Complications

Drill attempts and pain correlation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound-AssistedExperimental Treatment1 Intervention

After the usual landmark technique is performed and the potential site has been marked, procedure team physician will use the ultrasound machine to "fine tune" the drill site location.

Group II: LandmarkActive Control1 Intervention

For a landmark bone marrow biopsy procedure, the patient is first positioned either prone or lateral decubitus. The lateral, superior iliac crest is palpated and an attempt is made to follow the course of the posterior iliac crest until the posterior superior iliac spine (PSIS) is palpated. Additionally, the gluteal cleft is visualized indicating the patient midline. The area over the sacrum at midline is then palpated, proceeding laterally until the PSIS can be felt. The skin is marked with a marker at the estimated PSIS and point of entry.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for improving bone marrow biopsy procedures include the use of the Arrow® OnControl® Powered Bone Access System and ultrasound-assisted techniques. The ultrasound-assisted technique is particularly significant as it allows for precise identification of the posterior superior iliac spine (PSIS), ensuring accurate needle placement. This precision reduces procedural errors and enhances the quality of the biopsy sample, which is critical for accurate diagnosis and effective treatment planning for patients.

Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia.Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia.KRAS and NRAS mutation detection in circulating DNA from patients with metastatic colorectal cancer using BEAMing assay: Concordance with standard biopsy and clinical evaluation.