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Evaluation of Neuroma Perfusion With Indocyanine Green Fluorescence Angiography

Phase 4
Waitlist Available
Led By Gregory A Dumanian, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Clinical diagnosis of neuroma
Must not have
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
Minors, or age < 18 years old at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial looks at how blood flows to neuromas, which are nerve tumours, using a special imaging technique.

Who is the study for?
This trial is for adults over 18 with a clinical diagnosis of Morton's Neuroma who are scheduled for elective surgery to remove the neuroma. It excludes pregnant or breastfeeding women, those allergic to indocyanine green or iodides, individuals with allergic asthma, and patients with liver or kidney failure.
What is being tested?
The study aims to understand how blood flows through neuromas by using a special dye called indocyanine green during fluorescence angiography in patients undergoing surgical removal of the neuroma.
What are the potential side effects?
Potential side effects may include allergic reactions to the indocyanine green dye, especially in people who have allergies to iodides or have had allergic asthma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with a neuroma.
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I am scheduled for surgery to remove a nerve tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My surgery showed that the neuroma couldn't be fully exposed.
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I am under 18 years old.
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I am not a prisoner or decision-impaired.
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I have a history of allergic asthma.
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I have a history of liver failure.
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I have had kidney failure in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neuroma ICG Fluorescence Angiogram

Side effects data

From 2015 Phase 2 trial • 30 Patients • NCT01662752
97%
Wound pain
40%
Nausea
13%
Ileus
10%
Vomiting
7%
Bloating
7%
Urinary tract infection
3%
Postoperative ileus
3%
Tremor
3%
Dizziness
3%
Distended abdomen
3%
Epigastric pain
3%
Febrile reaction
3%
Low haemoglobin
3%
Groin pain
3%
Urinary retention
3%
Atelectasis
3%
Low blood pressure
3%
Atrial fibrillation
3%
Palpitations
3%
Paroxysmal atrial fibrillation
3%
Constipations
3%
Hiccough
3%
Rigors
3%
Confusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indocyanine Green

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neuroma ICGExperimental Treatment1 Intervention
Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
2016
Completed Phase 4
~1720

Find a Location

Who is running the clinical trial?

American Society for Surgery of the HandOTHER
10 Previous Clinical Trials
1,056 Total Patients Enrolled
1 Trials studying Neuroma
39 Patients Enrolled for Neuroma
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,490 Total Patients Enrolled
3 Trials studying Neuroma
76 Patients Enrolled for Neuroma
Gregory A Dumanian, MDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
10 Total Patients Enrolled
~14 spots leftby Jan 2026
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