Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

NCT06164392 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STU00220008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuroma; Neuroma Amputation; Neuroma of Upper Limb; Neuroma of Lower Limb

Keywords

Neuroma; Indocyanine Green; Targeted Muscle Reinnervation; Regenerative Peripheral Nerve Interface; Nerve Repair; Fluorescence Angiography

Outcome Measures

Primary Outcomes (1)

• Neuroma ICG Fluorescence Angiogram

  Nerve Tissue Perfusion as visualized by Fluorescence Angiogram

  Intraoperative

Study Arms (1)

Neuroma ICG

EXPERIMENTAL

Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma

Also known as: ICG

Neuroma ICG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• American Society for Surgery of the Hand: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60657, United States

Location

MeSH Terms

Conditions

Neuroma

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gregory A Dumanian, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Plastic surgery in the Department of Surgery

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: December 28, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: For one year following publication
• 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

Locations

US (1)