Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography

Study Overview

• Status: Withdrawn
• Conditions: Neuroma Amputation; Neuroma; Neuroma of Upper Limb; Neuroma of Lower Limb
• Intervention / Treatment: Drug: Indocyanine green

Detailed Description

Neuromas represent the frustrated regeneration of injured nerve axons encased in a bulbous scar. Symptomatic neuromas are particularly problematic in patients with amputations. Targeted Muscle Reinnervation is a novel surgical approach to neuroma treatment, resulting in improved residual limb pain in amputees. Nevertheless, a subset of Targeted Muscle Reinnervation patients achieve inadequate relief. Incomplete neuroma excision may be of particular concern in such cases, as failure to completely excise the neuroma risks leaving a scarred proximal nerve stump behind. Despite the critical importance of complete neuroma excision, there is no clear definition of a neuroma's "zone of injury". Indeed, intraoperatively determining where to cut a nerve to ensure accurate and complete excision of a neuroma at the time of reconstruction or repair is an unsolved problem in peripheral nerve surgery. The proposed research aims to characterize the perfusion of neuromas using fluorescence angiography. Specifically, we will test the hypothesis that intravascular indocyanine green (ICG) renders visible the perturbations in nerve perfusion associated with neuromas, and that these altered perfusion patterns correlate with the nerve's "zone of injury" as identified by histopathology. Ultimately, indocyanine green (ICG) fluorescence angiography may facilitate intraoperative decision-making at the time of neuroma excision.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Northwestern University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age > 18 years
• Clinical diagnosis of neuroma
• Scheduled elective surgery for neuroma excision

Exclusion Criteria:

• Minors, or age < 18 years old at the time of surgery
• Unable to provide written, informed consent
• Prisoners and decision-impaired individuals
• Pregnant or lactating women
• History of allergy to indocyanine green
• History of allergy to iodides
• History of allergic asthma
• History of hepatic failure
• History of renal failure
• Patients in whom the planned surgical incision/approach does not include excision of the neuroma
• Patients in whom adequate surgical exposure of the neuroma is unable to be obtained, as determined intraoperatively at the time of surgery by the Investigator or Co-Investigators
• Any subject who, at the discretion of the Investigator or Co-Investigators, is not suitable for inclusion in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuroma ICG; Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma	Drug: Indocyanine green; Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma; Other Names: ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroma ICG Fluorescence Angiogram	Nerve Tissue Perfusion as visualized by Fluorescence Angiogram	Intraoperative

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: American Society for Surgery of the Hand
• Investigators: Principal Investigator: Gregory A Dumanian, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2024
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 2, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Neuroma; Nerve Repair; Indocyanine Green; Regenerative Peripheral Nerve Interface; Targeted Muscle Reinnervation; Fluorescence Angiography
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Neuroma
• Other Study ID Numbers: STU00220008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant Data that underlie results in a publication
• IPD Sharing Time Frame: For one year following publication
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact gdumania@nm.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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