Ultrasound-Assisted vs. Landmark Bone Marrow Biopsy Techniques

(LUMP Trial)

Overseen By Joseph Puetz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Under 18, No biopsy indication, BMI ≥ 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two techniques for performing bone marrow biopsies, which assess conditions like leukemia and lymphoma. The landmark palpation bone marrow biopsy relies on feeling for bone landmarks to guide the procedure, while the ultrasound-assisted bone marrow biopsy uses ultrasound to pinpoint the best spot. The researchers aim to determine if ultrasound reduces pain or improves sample quality. The study seeks hospital patients already scheduled for a bone marrow biopsy to aid in a blood or cancer diagnosis. Participants must be able to give consent and speak English. As an unphased trial, this study offers patients the chance to contribute to research that could enhance biopsy techniques and patient comfort.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these bone marrow biopsy techniques are safe?

Research has shown that bone marrow biopsies are generally safe, whether using the traditional method or the newer ultrasound-assisted method. Complications are rare and may include minor issues like bleeding or soft tissue injury. Ultrasound allows doctors to see exactly where to place the needle, enhancing accuracy and safety. This precision might reduce pain and improve the patient experience. Overall, both methods are well-tolerated, with no major safety concerns reported in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether using ultrasound assistance can improve the accuracy of bone marrow biopsies compared to the traditional landmark technique. The ultrasound-assisted method allows doctors to "fine-tune" the site where the biopsy needle enters, potentially reducing the chances of errors and increasing the success rate of obtaining a good sample. Unlike the standard landmark method, which relies on feeling for specific bone landmarks, the addition of ultrasound provides a visual guide, which could lead to less discomfort for patients and more reliable results.

What evidence suggests that ultrasound-assisted bone marrow biopsy is effective for identifying the PSIS?

This trial will compare two techniques for bone marrow biopsy: the Ultrasound-Assisted method and the Landmark method. Research has shown that ultrasound can improve bone marrow biopsy procedures. Studies indicate that ultrasound helps doctors locate the correct biopsy site, resulting in higher quality samples. It also measures needle depth, reducing the chance of missing the target. This precision can lead to less pain during the procedure. Although not yet widely used for bone marrow biopsies, early evidence suggests this method could be more beneficial than traditional techniques. ^{1 2 5 6 7}

Who Is on the Research Team?

Devin Madenberg, DO

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Inpatient at Froedtert & MCW Froedtert Hospital requiring a bone marrow biopsy performed by the Medicine Bedside Procedure Team

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

Provide written informed consent to be on the study

Exclusion Criteria

Inpatient that does not consent to the procedure themselves or have a POA that does not consent to the procedure

Inpatient having no indication for bone marrow biopsy

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bone marrow biopsy using either the landmark palpation method or ultrasound-assisted technique

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for complications and pain assessment post-procedure

30 days

1 visit (in-person), 1 follow-up call

Outcome Assessment

Assessment of core and aspirate adequacy, pain correlation, and number of drill attempts

2 years

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Ultrasound-Assisted Experimental Treatment 1 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: Landmark Active Control 1 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.

Landmark palpation bone marrow biopsy is already approved in United States, European Union for the following indications:

Approved in United States as Landmark palpation bone marrow biopsy for:

• Cytopenia
• Leukemia
• Lymphoma
• Myelodysplastic syndrome
• Plasma cell dyscrasia

Approved in European Union as Landmark-guided bone marrow biopsy for:

• Cytopenia
• Leukemia
• Lymphoma
• Myelodysplastic syndrome
• Plasma cell dyscrasia

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

The study compared the traditional 2-needle technique with a 1-needle technique for bone marrow biopsies, evaluating 20 specimens from each method, and found that the 1-needle technique provided adequate samples for diagnosis.

The morphologic quality, biopsy length, and cellularity of samples obtained with the 1-needle technique were similar to those obtained with the 2-needle technique, suggesting that the 1-needle method may be a less painful and simpler alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between 1-needle technique versus 2-needle technique for bone marrow aspiration and biopsy procedures. Al-Ibraheemi, A., Pham, T., Chen, L., et al.[2022]

Bone marrow biopsy and aspiration are essential procedures for diagnosing and monitoring various conditions, including blood cancers and infections, highlighting their importance in medical practice.

Using imaging guidance, such as computed tomography and fluoroscopy, enhances the safety of these procedures, ensuring better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image Guided Bone Marrow Biopsy. Kaufman, CS., Kuo, KT., Anand, K.[2021]

Bone marrow biopsies performed with a triple-bevel needle resulted in shorter lengths of evaluable marrow (1.33 mm less) compared to those done with a single-bevel needle, indicating a potential compromise in sample quality.

The triple-bevel needle was significantly less effective, being five times more likely to yield inadequate specimens and 2.4 times more likely to produce hemodilute aspirates, suggesting that the choice of needle type is crucial for obtaining high-quality biopsy samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Biopsy Needle Type Affects Core Biopsy Specimen Length and Quality and Aspirate Hemodilution. Brestoff, JR., Toland, A., Afaneh, K., et al.[2019]

The powered bone marrow aspiration and biopsy device significantly reduced patient-reported pain during needle insertion (2.6 vs 4.1 on a pain scale) and decreased procedural time (100 seconds vs 224 seconds) compared to the traditional manual method, indicating improved patient comfort and efficiency.

Specimens obtained with the powered device were larger and of better quality (25.4 mm² vs 11.9 mm²), enhancing diagnostic yield and potentially reducing the need for repeat procedures, while no complications were reported in either method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. Swords, RT., Anguita, J., Higgins, RA., et al.[2022]

In a study comparing 30 motorized and 120 manual bone marrow biopsies, the manual device produced significantly less crush artifact, indicating better tissue quality for diagnosis.

While both methods showed no significant differences in overall biopsy size or adequacy, the manual method trended towards less aspiration artifact and intrastromal hemorrhage, suggesting it may be a safer option for obtaining quality samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Bone Marrow Biopsy Specimens Obtained Using a Motorized Device and Manual Biopsy Systems. Glennon, CA., Woodroof, JM., Kambhampati, S., et al.[2022]

The powered bone marrow biopsy system significantly reduces patient pain compared to manual methods, with a mean difference of -6.57 on a 100-point visual analogue scale, translating to a 17%-25% reduction in pain.

This powered system also increases the sample size of biopsies by an average of 3.65 mm, representing a 33% improvement, without increasing adverse events, making it a safer and more effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A powered bone marrow biopsy system versus manual methods: a systematic review and meta-analysis of randomised trials. Voigt, J., Mosier, M.[2022]

CT-guided bone marrow aspirations and biopsies resulted in significantly higher rates of adequate samples compared to blind procedures, with 95% of CT-guided samples deemed adequate versus 79% for blind procedures.

The CT-guided group also achieved longer core lengths (1.4 cm) compared to the blind group (1.0 cm), indicating improved sample quality, which is crucial for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-guided bone marrow aspirations and biopsies: retrospective study and comparison with blind procedures. Chang, CY., Husseini, JS., Moreira, A., et al.[2021]

In a study of 500 bone marrow biopsies, only 23% met the recommended length of ≥ 1.5 cm, yet 96% were still interpretable, indicating that core biopsy length may not be as critical for diagnostic adequacy as previously thought.

The number of intertrabecular areas evaluated was a better predictor of biopsy adequacy, with 100% of biopsies showing ≥ 5.5 intertrabecular areas being contributory, suggesting that adequacy criteria should be updated to reflect the importance of this measure in the context of modern ancillary testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting Bone Marrow Core Biopsy Adequacy Criteria in the Era of Extensive Ancillary Testing. O'Neill, SS., Wong, TC., Parris, J., et al.[2020]

Core needle biopsy of bone marrow is a safe and effective procedure that provides valuable diagnostic information, particularly for assessing marrow cellularity, metastatic tumors, and fibrosis, and is especially useful in diagnosing myelofibrosis.

While bone marrow biopsy should not replace aspiration smears, it serves as a complementary method that can yield specific diagnoses in cases where aspiration results are normal, highlighting the importance of using both techniques in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of bone marrow aspirate particle smears, imprints and biopsy sections. Sabharwal, BD., Malhotra, V., Aruna, S., et al.[2007]

Bone marrow biopsy and aspiration are essential procedures for diagnosing various blood-related conditions, but they are often painful for patients.

The paper reviews current strategies for reducing pain during these procedures, highlighting the need for improved pain management techniques to enhance patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies of pain reduction during the bone marrow biopsy. Hjortholm, N., Jaddini, E., Hałaburda, K., et al.[2022]

The new FDA-cleared battery-powered bone marrow biopsy system demonstrated safety and efficiency in both pre-clinical tests on pigs and clinical evaluations with 16 patients, with no complications reported.

The mean procedural time for the powered device was significantly faster (38.5 seconds) compared to traditional manual techniques, while maintaining equivalent specimen quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently. Swords, RT., Kelly, KR., Cohen, SC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05258357

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy ... 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 ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559232/

Bone Marrow Aspiration and Biopsy - StatPearls - NCBI - NIH Bone marrow aspiration and biopsies are often performed both in the inpatient and outpatient settings for the diagnosis of a multitude of hematologic disorders.

3. rsna.org rsna.org/-/media/files/rsna/practice-tools/quality-improvement/quality-improvement-reports/2024/enhancing-conventional-biopsies-t5b-qi-7-secured.pdf?rev=27da4ea711fb4bb69b62644ff795687f&hash=79EE286010AA1912BFD9ACD6FA9AA232

Ultrasound-Guided Percutaneous Bone Marrow Biopsy ... Ultrasound guidance, typically used for bone and focal lesions, is rarely used for bone marrow biopsies due to limitations in visualizing needle trajectory.

4. withpower.com withpower.com/trial/phase-bone-marrow-biopsy-procedure-3-2022-526ce

Ultrasound-Assisted vs. Landmark Bone Marrow Biopsy ... This trial tests if using ultrasound to guide bone marrow biopsies improves sample quality and reduces patient pain. It targets patients needing biopsies ...

5. trialstoday.org trialstoday.org/trial/NCT05258357

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy ... Therefore, this study will seek to provide evidence of benefits, or lack thereof, in using ultrasound for bone marrow biopsies. This will be ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667254522000191

Ultrasound-guided needle placement for bone marrow ... While bone marrow aspiration is generally considered a safe procedure, complications include injuries to soft tissue, bone, nerves and vasculature23, 24, 25, 26 ...

7. mayoclinic.org mayoclinic.org/tests-procedures/bone-marrow-biopsy/about/pac-20393117

Bone marrow biopsy and aspiration Risks. Bone marrow exams are generally safe procedures. Complications are rare but can include: Excessive bleeding, particularly in people with ...