NCT05258357: LUMP

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study

Active, enrolled NA Last updated 6 November 2025

What this trial tests

NA trial testing Ultrasound-assisted bone marrow biopsy in Bone Marrow Biopsy Procedure in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 May 2022

Primary endpoint
1 September 2026

1 December 2026

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	100
Start date	18 May 2022
Primary completion	1 September 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Ultrasound-assisted bone marrow biopsy
• Landmark palpation bone marrow biopsy

Conditions studied

• Bone Marrow Biopsy Procedure — all drugs for Bone Marrow Biopsy Procedure →

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Bone Marrow Biopsy Procedure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bone marrow biopsies are routinely performed by the Medicine Bedside Procedure Team service at Froedtert Hospital. Typical indications for inpatient bone marrow biopsies include evaluations for cytopenia, leukemia, lymphoma, myelodysplastic syndrome, or plasma cell dyscrasia. The bone marrow is sampled from the posterior iliac crest, ideally by drilling into the posterior superior iliac spine (PSIS). The Arrow® OnControl® Powered Bone Access System is utilized for this process. Most frequently, the location of the PSIS is estimated by using palpation of landmarks, such as the lateral iliac crests, spinous processes, sacrum, and the PSIS itself. Additionally, when using lidocaine to anesthetize the site, the needle is maneuvered to locate the most superficial portion of the PSIS, confirming the optimal drill anchor site. The correct direction/angle of the drill is estimated based on the orientation of the patient, typically directing it perpendicular to the coronal plane.

Palpating landmarks to identify the posterior superior iliac spine is often difficult due to patient body habitus. Ultrasonography allows for accurate identification of the PSIS. It allows the clinician to pinpoint the best entry point in the skin and optimal drill angle to drive the needle perpendicular to the coronal plane. Furthermore, it allows the clinician to measure the distance from the skin to the PSIS, ensuring the drill bit is anchored onto the correct site.

The benefits of an ultrasound approach have not been well documented. Therefore, this study will seek to provide evidence of benefits, or lack thereof, in using ultrasound for bone marrow biopsies. This will be achieved using a two-arm, open-label, randomized study design which will compare patient outcomes, as measured by pain assessment, bone marrow biopsy procedure metrics, and bone marrow biopsy sample quality, between subjects that have undergone the procedure using either the control landmark palpation method or ultrasound-assisted technique to properly identify the PSIS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.