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Ultrasound-Assisted vs. Landmark Bone Marrow Biopsy Techniques (LUMP Trial)
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 belowSelect...
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.
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 moreAwards & 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.
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.<i>KRAS</i> and <i>NRAS</i> mutation detection in circulating DNA from patients with metastatic colorectal cancer using BEAMing assay: Concordance with standard biopsy and clinical evaluation.
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.<i>KRAS</i> and <i>NRAS</i> mutation detection in circulating DNA from patients with metastatic colorectal cancer using BEAMing assay: Concordance with standard biopsy and clinical evaluation.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
633 Previous Clinical Trials
1,181,609 Total Patients Enrolled
Devin Madenberg, DOPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 and admitted to Froedtert & MCW Froedtert Hospital.I am 18 or older and admitted to Froedtert & MCW Froedtert Hospital.I am getting a bone marrow biopsy for cancer assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound-Assisted
- Group 2: Landmark
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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