Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

NCT05659433 | Completed

• 1 other identifier: CEUS-PBRT
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate). Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area. Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events. Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy. The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.

Conditions

Retroperitoneal Neoplasms

Keywords

Percutaneous biopsy; Contrast-enhanced ultrasonography; CEUS; Retroperitoneal neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of patients with a biopsy sample adequate for pathology interpretation

  4 weeks

Secondary Outcomes (2)

• Number of patients requiring a second biopsy due to prior inadequate sampling

  6 weeks

• Number of patients with procedural-related adverse events

  One week

Study Arms (2)

B-mode Ultrasound-guided Biopsy

ACTIVE COMPARATOR

Procedure: B-mode US-guided percutaneous biopsy

Contrast-enhanced Ultrasound-guided Biopsy

EXPERIMENTAL

Procedure: CEUS-guided percutaneous biopsy

Interventions

CEUS-guided percutaneous biopsy PROCEDURE

A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)

Contrast-enhanced Ultrasound-guided Biopsy

B-mode US-guided percutaneous biopsy PROCEDURE

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

B-mode Ultrasound-guided Biopsy

Eligibility Criteria

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

You may qualify if:

• All patients with retroperitoneal tumors with indication for percutaneous biopsy

You may not qualify if:

• Tumors inaccessible for ultrasound guided biopsy
• Standard contraindications for biopsy (altered coagulation tests, poor performance status)
• Lack of written informed consent

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead
• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: collaborator

Study Sites (1)

Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, 400162, Romania

Location

MeSH Terms

Conditions

Retroperitoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Zeno Spârchez, MD, Prof.

  Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2015
• Primary Completion: September 15, 2022
• Study Completion: November 30, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)