Diagnosing Compartment Syndrome With SHAPE vs Elastography

NCT05247541 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CG20003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic exertional compartment syndrome (CECS) is an innocuous condition seen primarily in 10-60% of young active people with exercise induced leg pain. With an average delay in diagnosis of 2 years, early identification is crucial as delays have led to poor surgical outcomes after fasciotomy. Diagnosis is currently made by compartment pressure (CP) testing, which is invasive, painful and demonstrates variable accuracy. There is no literature on the role of shear wave elastography (SWE) and/or subharmonic assisted pressure estimation (SHAPE) with microbubbles in diagnosing CECS. Ultrasound contrast agents are FDA-approved and are extremely safe. In this single-blinded prospective pilot study, the accuracy of SHAPE and SWE will be evaluated and compared to the current gold standard of compartment testing in patients with suspected CECS. Muscle stiffness and record a quantitative assessment of enhancement and hydrostatic pressures will be documented and correlated with compartment testing results based on a reference standard modified Pedowitz criteria for CECS

Conditions

Chronic Exertional Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• Accuracy in diagnosing

  Evaluate the ability of SHAPE with microbubbles and SWE to accurately diagnose chronic exertional compartment syndrome (CECS) in percent using ROC analysis.

  2 years

Study Arms (2)

Healthy Participants

ACTIVE COMPARATOR

Drug: Definity

Study participants

EXPERIMENTAL

Drug: Definity

Interventions

Definity DRUG

Definity (Lantheus Medical Imaging, N Billerica, MA) in 50 mL of saline infused over 5-10 minutes

Healthy Participants; Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CECS as the primary diagnosis with no other more likely diagnoses.
• Age over 18.

You may not qualify if:

• Medial tibial stress syndrome or tibial stress fractures diagnosed on MRI.
• Recent trauma/surgery to the lower extremity
• Pregnant
• Stress fractures of the lower extremity
• Diabetic neuropathy
• Peripheral vascular disease
• Pressure ulcers or treatment for pressure ulcers
• Coronary artery disease
• Active pulmonary disease
• Allergy to any components of Definity.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Lantheus Medical Imaging: collaborator
• Rothman Institute Orthopaedics: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Chronic Exertional Compartment Syndrome

Interventions

perflutren

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Flemming Forsberg, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will be performed as a prospective nonblinded pilot study.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 21, 2022
• Study Start: July 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)