Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy (COLD SNAP)

Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.

Study Overview

• Status: Not yet recruiting
• Conditions: Cryobiopsy of Peripheral Lymph Nodes
• Intervention / Treatment: Procedure: Core Needle Biopsy; Procedure: Cryobiopsy; Device: Cryobiopsy

Detailed Description

Peripheral lymph node biopsy has long been accomplished to establish malignant and non-malignant diagnoses of lymphadenopathy. For several decades patients have undergone fine needle aspiration (FNA) and core needle biopsy (CNB) with patient's proceeding to excisional biopsy if initial less invasive procedures are inadequate. The diagnostic yield of FNA followed by CNB has remained stagnant since the 1990's with a yield range of 66-93.6% depending on multiple factors such as patient factors and malignancy type. In one study they found that between 25-30% of patients undergoing FNA followed by CNB ultimately proceed to excisional biopsy which carries a higher rate of morbidity than FNA or CNB with complications including: Seroma 6.4%, Hematoma 3.2%, Dehiscence 1.8% and prolonged pain 1.4%, vs. CNB which has a less than 1% overall complication rate. In several malignancy types, but especially in lymphoproliferative disorders there is a gap in the ability to diagnose via CNB.

After the introduction of cryobiopsy for bronchoscopic lymph node biopsy there was a significant increase in yields with the most prominent increase seen among the lymphoproliferative disorders with an increase from 69% to 95%. Cryobiopsy samples had a significant increase in architecture which is critical in proper diagnosis of lymphoproliferative disorders and genetic sequencing. Bronchoscopic cryobiopsies of mediastinal lymph nodes did not demonstrate higher complication rates compared to fine needle aspiration despite the higher yields.

Thus far in the literature the use of cryobiopsy for the diagnosis of superficial peripheral lymph nodes of suspected malignant potential has not yet been described. The use of the ERBE 2 platform for tissue biopsy has been demonstrated to improve the diagnostic yield in some situations, such as mediastinal lymphadenopathy, without statistically significant increase in complications. This study seeks to evaluate the safety, feasibility, and effectiveness of the use of the 1.1mm cryoprobe of this platform to increase diagnostic yield of peripherally obtainable lymph nodes of malignant potential without the need for additional procedures such as excisional biopsy that carry a significantly increased risk compared to current initial biopsy methods such as FNA and CNB.

• Study Type: Interventional
• Enrollment (Estimated): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
      • Contact: Steven Stoffel, DO; Phone Number: 210-916-2153; Email: steven.t.stoffel.mil@health.mil
      • Sub-Investigator: Michal Sobieszczyk, MD
      • Sub-Investigator: Stephen Goertzen, DO
      • Principal Investigator: Steven Stofffel, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-89
• Suspected or confirmed malignancy with suspected involvement of peripheral lymph nodes based on CT, PET-CT or ultrasound imaging with a clinical need for additional tissue or staging by tissue sampling

Exclusion Criteria:

• Age <18 or >89
• Patient preference
• Severe allergy to lidocaine precluding use
• Severe allergy to chlorhexidine precluding use
• Overlying Infection
• Active anticoagulation or anti-platelet therapy, with the exception of aspirin mono-therapy, that cannot be safely held as determined by the performing or prescribing physician.
• Major organs, vasculature or tissue that would preclude the safety of the procedure as determined by the performing physician.
• Inability to reach the lymph node through a core needle introducer sheath as determined by the performing physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; FNA followed by Core Needle biopsy	Procedure: Core Needle Biopsy; Core Needle Biopsy
Experimental: Experimental Arm; FNA followed by cryobiopsy through a introducer sheath	Procedure: Cryobiopsy; Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling; Device: Cryobiopsy; Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Yield by strict criteria	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Complication Rate	30 days
Patient reported pain on Stanford Comparative Pain Scale	5 days
Need for Repeat procedures	30 days
Ability to proceed to next generation sequencing based on tissue obtained	30 days

Collaborators and Investigators

• Sponsor: San Antonio Uniformed Services Health Education Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lymphoma; Cryobiopsy; Peripheral Lymphadenopathy; Malignancy Staging
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: C.20231002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Following completion of analysis, the electronic medical record query will be destroyed and the Research Database will be de-identified by removing all remaining dates.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No