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Dye
ICG Dye Imaging for Cancer Surgery
Phase 2
Recruiting
Led By Santiago A Lozano-Calderon, 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
All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether using a dye called indocyanine green during surgery to remove tumors will help surgeons better see the edges of the tumor and remove it all. They will also look at whether this method leads to better outcomes for patients.
Who is the study for?
This trial is for adults over 18 with benign or malignant bone or soft tissue masses who are undergoing surgery at Massachusetts General Hospital's Orthopaedic Surgery Department. It excludes those in renal failure not cleared for ICG, pregnant or nursing individuals, and patients with known anaphylaxis to IV contrast or iodine.Check my eligibility
What is being tested?
The study tests the effectiveness of using a dye called indocyanine green (ICG) during surgical removal of tumors to achieve clear margins. The goal is to see if this method reduces local recurrence, delays metastasis, and improves survival rates compared to traditional methods.See study design
What are the potential side effects?
Potential side effects may include allergic reactions in those sensitive to dyes like ICG. Since it's used intraoperatively, risks are generally related to the procedure itself rather than long-term medication use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a bone or soft tissue mass and am scheduled for surgery at Massachusetts General Hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
image-guided prediction of local recurrence
Secondary outcome measures
Distant recurrence (metastatic disease)
physician-perceived vs. device measured negative margins
Trial Design
1Treatment groups
Experimental Treatment
Group I: ICG Dye and use of SPY-PHI ImagingExperimental Treatment2 Interventions
ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal
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?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,541 Total Patients Enrolled
Santiago A Lozano-Calderon, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
1,434 Total Patients Enrolled
Santiago A Lozano-Calderon, MD. PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious allergic reaction to IV contrast or iodine in the past. Other allergies may also be considered.You are pregnant or currently breastfeeding.My doctor says I can't have ICG due to kidney failure.I am 18 or older with a bone or soft tissue mass and am scheduled for surgery at Massachusetts General Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: ICG Dye and use of SPY-PHI Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have signed up for the trial thus far?
"Affirmative. Clinicaltrials.gov reveals that this investigation is actively seeking patients, having been first uploaded on May 25th 2022 and last updated August 23rd of the same year. The trial has a goal of recruiting 100 individuals at one location."
Answered by AI
Is this procedure likely to produce any adverse effects in individuals?
"The safety of this treatment is evaluated as a 2 due to its Phase 2 status, which implies that preliminary data exists on the medication's safety but no evidence backing efficacy has been uncovered."
Answered by AI
Are there any enrolment opportunities for this experiment at the moment?
"This trial is still seeking to fill its ranks, as evidenced by the posting on clinicaltrials.gov first made public on May 25th 2022 and most recently updated towards the end of August that same year."
Answered by AI
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