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Indocyanine Green Dye for Nervous System Cancer
Phase 1
Waitlist Available
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
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 surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a dye injection can help doctors find and tell the difference between cancer and normal tissue.
Who is the study for?
This trial is for adults over 18 with nervous system tumors that can be surgically removed and are at risk of coming back. Candidates must be in good enough health for surgery as judged by their doctors, and able to give informed consent. Pregnant women, those allergic to iodide, patients unable to consent, with uncontrolled high blood pressure or from vulnerable populations cannot join.
What is being tested?
The study tests if a low-dose indocyanine green (ICG) dye injected into the vein on the same day as surgery helps distinguish tumor tissue from normal tissue during operations using a special imaging system.
What are the potential side effects?
Potential side effects may include reactions related to ICG such as nausea or an allergic reaction. However, since ICG is FDA-approved and used at low doses, significant side effects are not commonly expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NIR Efficiency
NIR True Positive Rate
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
Secondary study objectives
Association Between Resection Decision and Pathology
Negative Predictive Value
Positive Predictive Value
+3 moreAwards & Highlights
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: SWIG ArmExperimental Treatment1 Intervention
This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,408 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
165,109 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor and their team consider me a good candidate for surgery.I am 18 years old or older.I have high blood pressure that's hard to control and have been to the ER or take 3+ medications for it.My brain or spinal tumor is likely removable and may come back after surgery.I am unable to give consent by myself.
Research Study Groups:
This trial has the following groups:- Group 1: SWIG Arm
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.
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