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ICG Intervention for Sentinel Lymph Node

Phase 1 & 2

Waitlist Available

Led By Yolonda L Colson, MD, PhD

Research Sponsored by Massachusetts General Hospital

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 5 years

Awards & highlights

Study Summary

This trial is testing a new way to find and remove lung tumors and the lymph nodes that drain from them. The hope is that this will improve the ability to detect and remove tumor cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of treatment-emergent adverse events (safety and feasibility) of intraoperative NIR-image-guided localization of lung lesions using peritumoral ICG injection.

Secondary outcome measures

Assess if NIR image-guided SLN excision enhances detection of metastatic disease and whether the presence of untreated occult metastatic disease/mutational analysis of primary tumors/secondary sites of disease including SLNs are predictors of outcome

Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ICG InterventionExperimental Treatment2 Interventions

The intervention to be administered is the indocyanine green for NIR Lymphatic Mapping. All study subjects will receive this same intervention; there is only one arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ICG Intervention

2016

Completed Phase 2

~30

Near Infrared Imaging

2013

Completed Phase 1

~10

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Find a Location

Who is running the clinical trial?

Society of University SurgeonsOTHER

4 Previous Clinical Trials

405 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,612 Previous Clinical Trials

11,470,475 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,345 Total Patients Enrolled

Frequently Asked Questions

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

What is the participant capacity for this scientific research?

"Affirmative. Clinicaltrials.gov confirms that this research endeavour, which was first introduced on the 6th of January 2015, is currently recruiting patients. In total, 100 participants are needed for recruitment at one medical site."

Answered by AI

Is this experiment still providing opportunities for participants?

"Affirmative. According to clinicaltrials.gov, the trial is actively seeking enrolment with updates having been made as recently as April 22nd 2022 after first being posted on June 1st 2015. One hundred volunteers are needed from a single site for this project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bronchial NIR Image-guided Resection

Yolonda Colson, MD, PhD 2015. "Bronchial NIR Image-guided Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03097575.