Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy

NCT06120829 | Unknown FDA Device

• 1 other identifier: C.20231002
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cryobiopsy of Peripheral Lymph Nodes

Keywords

Cryobiopsy; Peripheral Lymphadenopathy; Lymphoma; Malignancy Staging

Outcome Measures

Primary Outcomes (1)

• Yield by strict criteria

  7 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

FNA followed by Core Needle biopsy

Procedure: Core Needle Biopsy

Experimental Arm

EXPERIMENTAL

FNA followed by cryobiopsy through a introducer sheath

Procedure: Cryobiopsy; Device: Cryobiopsy

Interventions

Cryobiopsy PROCEDURE

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Experimental Arm

Core Needle Biopsy PROCEDURE

Core Needle Biopsy

Control Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Antonio Uniformed Services Health Education Consortium: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Critical Care Fellow

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)