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Indocyanine green for Gallbladder Inflammation (ICG Trial)

Phase 2

Waitlist Available

Led By Ali Zarrinpar, MD, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

ICG Trial Summary

This trial is testing whether a lower dose of indocyanine green (ICG) can be used for near-infrared fluorescence (NIRF) imaging to help surgeons identify liver anatomy during surgery.

Eligible Conditions

Gallbladder Inflammation
Liver Cancer
Liver Metastases

ICG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative, average of 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative, average of 2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative, average of 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio

Secondary outcome measures

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light

Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio

Other outcome measures

Qualitative assessment of overall intraoperative visualization of the extrahepatic biliary tree (common hepatic duct, cystic duct, common bile duct, aberrant ducts)

ICG Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low DoseExperimental Treatment2 Interventions

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Group II: Standard DosePlacebo Group2 Interventions

Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

2016

Completed Phase 4

~1720

PINPOINT Endoscopic Fluorescence

2021

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,618 Total Patients Enrolled

Society of University SurgeonsOTHER

4 Previous Clinical Trials

445 Total Patients Enrolled

Ali Zarrinpar, MD, PhDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

19 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this experiment still be effective for patients who are 50 or older?

"The age range for patients that this study is recruiting are those who are over 18 and below 80 years old."

Answered by AI

Can I be a subject in this experiment?

"Those who suffer from cholecystitis and are between 18-80 years old may be able to participate in this 105 person clinical trial."

Answered by AI

Has Indocyanine green received federal approval for medical use?

"Given that this is a Phase 2 trial and there is some safety data but no efficacy data, our team has rated Indocyanine green as a 2 in terms of safety."

Answered by AI

How many individuals are enrolled in this study?

"According to the latest update on clinicaltrials.gov, this research is still looking for individuals to take part in the study. The posting went up on September 15th 2021 with the most recent update being November 16th, 2021. They are hoping to get 105 people to participate at 1 location."

Answered by AI

Are there any patients that this research is currently not involving?

"The clinicaltrials.gov website lists this study as currently having an open call for participants. This trial was first announced on September 15th, 2021 and underwent its most recent edit on November 16th, 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low Dose ICG for Biliary Tract and Tumor Imaging

2021. "Low Dose ICG for Biliary Tract and Tumor Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04942665.